A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

May 31, 2026 updated by: Boehringer Ingelheim

EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.

Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:

  • Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day.
  • Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day.

Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.

The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Bahía Blanca, Argentina, B8000FTD
      • Buenos Aire, Argentina, C1425
      • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
        • Recruiting
        • Glenny Corp. S.A. Bioclinica Argentina
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
      • Ciudad Autonoma Buenos Aires, Argentina, C1128AAF
      • Ciudad Autonoma Buenos Aires, Argentina, C1428ART
      • Ciudad Autonoma Buenos Aires, Argentina, C1056ABJ
        • Recruiting
        • Centro de Investigaciones Metabolicas (CINME)-Ciudad Autonoma Buenos Aires-41221
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1428DCO
        • Recruiting
        • Instituto Cardiovascular de Buenos Aires
        • Contact:
      • Ciudad Autonoma de Bs As, Argentina, A1120AAC
      • Ciudad Autónoma de Bs As, Argentina, C1181ACH
      • Ciudadela, Argentina, 1702
        • Recruiting
        • Instituto Medico Elsa Perez SRL (IMEP)
        • Contact:
      • Coronel Suárez, Argentina, B7540GHD
      • Córdoba, Argentina, X5000JHQ
      • Córdoba, Argentina, X5002HWE
      • Córdoba, Argentina, X5003DCE
      • Córdoba, Argentina, X5006CBI
      • Córdoba, Argentina, X5002AOQ
        • Recruiting
        • Sanatorio Privado Duarte Quiros De Clinica Colombo SA
        • Contact:
      • Mar del Plata, Argentina, B7600FYK
        • Recruiting
        • Centro de Investigaciones Medicas Mar Del Plata
        • Contact:
      • Pilar, Argentina, B1629ODT
      • Quilmes, Argentina, B1878GEG
        • Recruiting
        • Instituto de Investigaciones Clínicas de Quilmes
        • Contact:
      • Ramos Mejía, Argentina, 1704
      • Rosario, Argentina, S2000PBJ
      • Rosario, Argentina, 2000
        • Recruiting
        • Instituto de Investigaciones Clinicas de Rosario
        • Contact:
      • Salta, Argentina, A4406BFP
      • San Martin, Argentina, B1650CSQ
        • Not yet recruiting
        • Corporacion Medica de Gral. San Martin S.A.
        • Contact:
      • San Miguel de Tucumán, Argentina, T4000ICL
      • San Miguel de Tucumán, Argentina, T4000IAI
        • Not yet recruiting
        • Investigaciones en Patologias Respiratorias
        • Contact:
      • San Miguel de Tucumán, Argentina, T4000
        • Not yet recruiting
        • Centro Modelo de Cardiologia
        • Contact:
      • San Miguel de Tucumán, Argentina, T4000
      • San Nicolás, Argentina, B2900DMH
        • Recruiting
        • Instituto de Investigaciones Clinicas San Nicolas
        • Contact:
      • Santa Fe, Argentina, S3000FWO
        • Recruiting
        • Centro de Investigaciones Clínicas del Litoral
        • Contact:
      • Villa Luro, Argentina, 1407
        • Recruiting
        • CEMEDIC - Centro de Especialidades Medicas
        • Contact:
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
      • Gosford, New South Wales, Australia, 2250
      • Kingswood, New South Wales, Australia, 2747
      • Kotara, New South Wales, Australia, 2289
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Not yet recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
      • Chermside, Queensland, Australia, 4032
      • Tugun, Queensland, Australia, 4224
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Woodville, South Australia, Australia, 5011
    • Victoria
      • Frankston, Victoria, Australia, 3199
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Belgium
      • Genk, Belgium, 3600
      • Ghent, Belgium, 9000
      • Gilly, Belgium, 6060
      • Hasselt, Belgium, 3500
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
  • Brazil
      • Aracaju, Brazil, 49055-530
        • Not yet recruiting
        • Centro de Pesquisa Clinica do Coracao
        • Contact:
      • Belo Horizonte, Brazil, 30150-240
        • Recruiting
        • Cardresearch Cardiologia Assistencial e de Pesquisas Ltda
        • Contact:
      • Belo Horizonte, Brazil, 30140-092
      • Belo Horizonte, Brazil, 30110-934
        • Not yet recruiting
        • Hospital Felicio Rocho
        • Contact:
      • Bragança Paulista, Brazil, 1291-6542
        • Not yet recruiting
        • Hospital Universitário São Francisco na Providência de Deus
        • Contact:
      • Brasília, Brazil, 70200-730
        • Recruiting
        • L2IP -Instituto de Pesquisas Clínicas Ltda.
        • Contact:
      • Brasília, Brazil, 70710-100
        • Recruiting
        • CECAP - Centro de Cardiologia Clínica
        • Contact:
      • Brasília, Brazil, 70390-140
        • Not yet recruiting
        • Hospital DF Star
        • Contact:
      • Brasília, Brazil, 70390-903
        • Not yet recruiting
        • Hospital do Coracao do Brasil
        • Contact:
      • Brasília, Brazil, 71635-580
        • Not yet recruiting
        • Hospital Brasilia
        • Contact:
      • Campina Grande do Sul, Brazil, 83430-000
        • Recruiting
        • Hospital Angelina Caron
        • Contact:
      • Campinas, Brazil, 13060-080
        • Recruiting
        • IPECC - Instituto de Pesquisa Clinica de Campinas
        • Contact:
      • Campinas, Brazil, 13092-133
        • Recruiting
        • Centro Especializado em Cardiol Loema Instituto de Pesq Clin
        • Contact:
      • Campo Largo, Brazil, 83606-177
      • Curitiba, Brazil, 80230-130
        • Recruiting
        • PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PR
        • Contact:
      • Goiânia, Brazil, 74223-130
      • Marília, Brazil, 17515-000
        • Recruiting
        • ICM - Instituto do Coracao de Marilia
        • Contact:
      • Natal, Brazil, 59020-035
        • Not yet recruiting
        • Instituto Atena de Pesquisa Clinica
        • Contact:
      • Passo Fundo, Brazil, 99010-120
        • Recruiting
        • Instituto Mederi de Pesquisa e Saude
        • Contact:
      • Porto Alegre, Brazil, 90430-001
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • Santa Casa de Misericórdia de Porto Alegre
        • Contact:
      • Porto Alegre, Brazil, 90840-440
        • Recruiting
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade Simples
        • Contact:
      • Recife, Brazil, 50070-480
        • Not yet recruiting
        • Hospital Esperança Recife
        • Contact:
      • Ribeirão Preto, Brazil, 14048-900
        • Recruiting
        • Hospital das Clínicas FMRP-USP
        • Contact:
      • Ribeirão Preto, Brazil, 14026-900
        • Not yet recruiting
        • Clinicor Clínica Cardiológica LTDA/ Cardio Prime - CAPED
        • Contact:
      • Rio Do Janeiro, Brazil, 22270-060
        • Recruiting
        • Ruschel Medicina e Pesquisa Clínica
        • Contact:
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • Instituto Brasil de Pesquisa Clinica (IBPClin)
        • Contact:
      • Salvador, Brazil, 40170-310
        • Not yet recruiting
        • Hospital Cardio Pulmonar
        • Contact:
      • Santo André, Brazil, 09080-110
      • Santo André, Brazil, 09090-970
      • Sao Jose Rio Preto, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
      • São Luís, Brazil, 65060-645
        • Not yet recruiting
        • Hospital São Domingos
        • Contact:
      • São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica
        • Contact:
      • São Paulo, Brazil, 01228-200
        • Recruiting
        • CPCLIN - Centro de Pesquisas Clínicas Ltda.
        • Contact:
      • Uberlândia, Brazil, 38411-186
        • Not yet recruiting
        • Eurolatino Pesquisas Médicas Ltda.
        • Contact:
      • Vitória, Brazil, 29055-450
        • Recruiting
        • CEDOES - Diagnóstico e Pesquisa,Vitória
        • Contact:
      • Votuporanga, Brazil, 15501-405
        • Recruiting
        • Integral Pesquisa e Ensino
        • Contact:
  • Bulgaria
      • Burgas, Bulgaria, 8008
      • Dimitrovgrad, Bulgaria, 6400
      • Gotse Delchev, Bulgaria, 2900
      • Kardzhali, Bulgaria, 6600
      • Kyustendil, Bulgaria, 2500
        • Recruiting
        • Medical Center Hera - Kyustendil EOOD
        • Contact:
      • Pernik, Bulgaria, 2300
        • Recruiting
        • Ambulatory Individual Practice for Cardiology Specialized Medical Care
        • Contact:
      • Pleven, Bulgaria, 5800
      • Pleven, Bulgaria, 5800
      • Pleven, Bulgaria, 5803
        • Recruiting
        • Ambulatory for Individual Practice for Specialized Medical Care in Cardiology - Dr Nikolay Iliev
        • Contact:
      • Plovdiv, Bulgaria, 4002
      • Rousse, Bulgaria, 7013
      • Sofia, Bulgaria, 1510
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Multiprofile Hospital MHATEM 'Pirogov', Sofia
        • Contact:
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1680
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Diagnostic Consultative Center Alexandrovska
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD
        • Contact:
      • Sofia, Bulgaria, 1680
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Diagnostic Consultation Center XX-Sofia EOOD
        • Contact:
      • Sofia, Bulgaria, 1756
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1618
      • Sofia, Bulgaria, 1582
        • Recruiting
        • ASOMHIDC - Individual practice "Cardio Tonus" EOOD
        • Contact:
      • Sofia, Bulgaria, 1309
        • Recruiting
        • Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
        • Contact:
      • Sofia, Bulgaria, 1233
        • Recruiting
        • National Multiprofile Transport Hospital "Tzar Boris III"
        • Contact:
      • Stara Zagora, Bulgaria, 6000
        • Not yet recruiting
        • UMHAT Prof. Dr. Stoyan Kirkovich AD
        • Contact:
      • Stara Zagora, Bulgaria, 6010
      • Varna, Bulgaria, 9000
        • Recruiting
        • Diagnostichno-Consultativen Center Chaika EOOD
        • Contact:
      • Veliko Tarnovo, Bulgaria, 5006
      • Yambol, Bulgaria, 8600
      • Yambol, Bulgaria, 8600
        • Terminated
        • MHAT St Panteleimon
  • Canada
      • Edmonton, Canada, T5H 3V9
        • Recruiting
        • Royal Alexandra Hospital (Edmonton)
        • Contact:
      • Greater Sudbury, Canada, P3E 5J1
      • Kitchener, Canada, N2H5Z8
        • Not yet recruiting
        • Clinical Research Solutions Inc. (Kitchener)
        • Contact:
      • Montreal, Canada, H3G 1A4
        • Recruiting
        • Montreal General Hospital - McGill University Health Centre
        • Contact:
      • Montreal, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
      • Saint-Jean-sur-Richelieu, Canada, J3A 1J2
        • Not yet recruiting
        • CardioVasc HR Inc.
        • Contact:
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Recruiting
        • Cambridge Cardiac Care Centre
        • Contact:
      • Hamilton, Ontario, Canada, L8L 0A9
        • Not yet recruiting
        • Curnew Medicine Professional Corporation
        • Contact:
      • Mississauga, Ontario, Canada, L5K 2L3
        • Recruiting
        • KMH Cardiology Centres (Mississauga)
        • Contact:
      • Oakville, Ontario, Canada, L6M 0L8
        • Not yet recruiting
        • Oakville Trafalgar Memorial Hospital
        • Contact:
      • Oshawa, Ontario, Canada, L1J 2K1
      • Peterborough, Ontario, Canada, K9J 0B2
        • Recruiting
        • Kawartha Cardiology Clinical Trials
        • Contact:
      • Sarnia, Ontario, Canada, N7T 4P5
        • Recruiting
        • CardioQuest Research Centre
        • Contact:
      • Stoney Creek, Ontario, Canada, L8J 3W2
        • Recruiting
        • KMH Cardiology Centers (Hamilton)
        • Contact:
      • Toronto, Ontario, Canada, M6G 1M2
        • Recruiting
        • Diabetes Heart Research Centre
        • Contact:
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Recruiting
        • ViaCar Recherches Cliniques Inc. (Greenfield Park)
        • Contact:
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • Jewish General Hospital
        • Contact:
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
        • Diex Recherche (Trois-Rivieres)
        • Contact:
  • Chile
      • Puerto Varas, Chile, 5550170
        • Not yet recruiting
        • Quantum Research Santiago, Puerto Varas
        • Contact:
      • Santiago, Chile, 8900000
        • Recruiting
        • Sociedad Medica Cardiologica El Llano
        • Contact:
      • Talcahuano, Chile, 4270918
        • Recruiting
        • Hospital Las Higueras
        • Contact:
      • Temuco, Chile, 4780000
      • Viña del Mar, Chile, 2570017
        • Recruiting
        • CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar
        • Contact:
  • China
      • Baotou, China, 014040
        • Recruiting
        • Baotou Central Hospital
        • Contact:
      • Baotou, China, 014010
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College
        • Contact:
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100029
        • Recruiting
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:
      • Beijing, China, 100037
        • Recruiting
        • Cardiovascular Institute and Fu Wai Hospital
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, China, 130033
        • Recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • Jilin Province People's Hospital
        • Contact:
      • Changde, China, 415001
        • Recruiting
        • Changde Second People's Hospital
        • Contact:
      • Changsha, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, China, 410015
        • Recruiting
        • The Third Hospital of Changsha
        • Contact:
      • Changsha, China, 410004
        • Recruiting
        • Changsha Central Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610500
        • Recruiting
        • The First Affiliated Hospital of Chengdu Medical College
        • Contact:
      • Chengdu, China, 610021
        • Not yet recruiting
        • Chengdu Second People's Hospital
        • Contact:
      • Chenzhou, China, 423000
        • Recruiting
        • Chenzhou No.1 people's Hospital
        • Contact:
      • Dalian, China, 116001
        • Recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
      • Daqing, China, 163711
        • Not yet recruiting
        • Daqingshi People's Hospital
        • Contact:
      • Daqing, China, 163001
        • Recruiting
        • Daqing Oilfield General Hospital
        • Contact:
      • Deyang, China, 618099
        • Recruiting
        • Deyang People's Hospital
        • Contact:
      • Foshan, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Fuzhou, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Fuzhou, China, 350025
        • Not yet recruiting
        • No.900 Hospital of PLA Joint Logistics Support Force
        • Contact:
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510150
        • Recruiting
        • Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, China, 511400
        • Recruiting
        • The Affiliated Panyu Central Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, China, 510120
        • Recruiting
        • Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
        • Contact:
      • Guangzhou, China, 510400
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
      • Guiyang, China, 550000
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Guiyang, China, 550002
        • Recruiting
        • Guizhou People's Hospital
        • Contact:
      • Haikou, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Contact:
      • Hangzhou, China, 311199
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
      • Harbin, China, 150040
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
      • Huainan, China, 232007
        • Recruiting
        • Huainan First People's Hospital
        • Contact:
      • Jiangmen, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
      • Jinan, China, 250013
        • Recruiting
        • Center Hospital of Jinan
        • Contact:
      • Jining, China, 272011
        • Recruiting
        • Jining No.1 people's hospital
        • Contact:
      • Lanzhou, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Linfen, China, 041000
        • Recruiting
        • Linfen Central Hospital
        • Contact:
      • Luoyang, China, 471002
        • Recruiting
        • Luoyang Third People's Hospital
        • Contact:
      • Luoyang, China, 471000
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, China, 330003
        • Recruiting
        • Jiangxi Province Integrated Tractional Chinese Medicine& Western Medicine Hospital
        • Contact:
      • Nanchang, China, 330009
        • Recruiting
        • Nanchang People's Hospital
        • Contact:
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, China, 211100
        • Recruiting
        • Nanjing Jiangning Hospital
        • Contact:
      • Nanning, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Nanyang, China, 473009
        • Recruiting
        • Nanyang Second General Hospital
        • Contact:
      • Nanyang, China, 473004
        • Recruiting
        • Nanyang First People's Hospital
        • Contact:
      • Panjin, China, 124010
        • Not yet recruiting
        • Panjin Liao Oil Gem Flower Hospital
        • Contact:
      • Pingxiang, China, 337055
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200050
        • Recruiting
        • Tongren hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shengyang, China, 110004
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:
      • Shenzhen, China, 518172
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
      • Shijiazhuang, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Tianjin, China, 300121
        • Recruiting
        • Tianjin Union Medical Center Nankai University Affiliated Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • Wenzhou People's Hospital
        • Contact:
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, China, 430032
        • Recruiting
        • Hubei Province Zhongshan Hospital
        • Contact:
      • Wuhan, China, 430033
      • Xi'an, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
      • Xiangtan, China, 411100
        • Recruiting
        • Xiangtan Central Hospital
        • Contact:
      • Xinxiang, China, 453003
        • Recruiting
        • The Third Affiliated Hospital of Xinxiang Medical University
        • Contact:
      • Xuancheng, China, 242000
        • Recruiting
        • The People's Hospital Of Xuancheng City
        • Contact:
      • Xuzhou, China, 221006
        • Recruiting
        • The General Hospital of XZCMG (The Second Affiliated Hospital of Xuzhou Medical University)
        • Contact:
      • Yanji, China, 133000
        • Recruiting
        • Yanbian University Hospital
        • Contact:
      • Yinchuan, China, 750001
        • Recruiting
        • The first People's Hosptal of Yinchuan
        • Contact:
      • Yueyang, China, 414000
        • Recruiting
        • Yueyang Central Hospital
        • Contact:
      • Yuncheng, China, 44000
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
      • Zhangjiakoou, China, 75000
        • Recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
      • Zhengzhou, China, 450052
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhenjiang, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
  • Colombia
      • Armenia, Colombia, 630004
      • Barranquilla, Colombia, 80020
        • Recruiting
        • Centro de Investigacion Medico Asistencial S.A.S
        • Contact:
      • Barranquilla, Colombia, 080020
        • Recruiting
        • IPS Centro Cientifico-Asistencial S.A.S
        • Contact:
      • Barranquilla, Colombia, 74158
      • Cali, Colombia, 760001
        • Recruiting
        • IPS Centro Medico Julián Coronel S.A.
        • Contact:
      • Cartagena, Colombia, 130001
        • Recruiting
        • Centro De Diagnostico Cardiologico Ltda
        • Contact:
      • Floridablanca, Colombia, 6810002
        • Recruiting
        • Fundacion Cardiovascular de Colombia
        • Contact:
      • Manizales, Colombia, 170004
        • Recruiting
        • IPS médicos internistas de Caldas S.A.S.
        • Contact:
      • Medellín, Colombia, 05001
        • Not yet recruiting
        • Fundacion Centro de Investigacion Clinica CIC
        • Contact:
      • Pereira, Colombia, 66001
      • Santa Marta, Colombia, 470001
        • Recruiting
        • T Y C Inversiones S.A.S Grupsalud
        • Contact:
      • Zipaquirá, Colombia, 250252
        • Recruiting
        • Healthy Medical Center S.A.S, Zipaquirá
        • Contact:
  • Czechia
      • Brandýs nad Labem, Czechia, 250 01
        • Recruiting
        • Medicus Services s.r.o.
        • Contact:
      • Brandýs nad Labem, Czechia, 25001
        • Recruiting
        • Interni Ordinace s.r.o.
        • Contact:
      • Brno, Czechia, 62500
        • Recruiting
        • University Hospital Brno
        • Contact:
      • Brno, Czechia, 625 00
        • Not yet recruiting
        • University Hospital Brno
        • Contact:
      • Brno, Czechia, 602 00
        • Recruiting
        • MUDr. Libor Nechvatal s.r.o.
        • Contact:
      • Brno, Czechia, 602 00
      • Brno, Czechia, 603 00
        • Recruiting
        • MUDr. Karel Kamenik s.r.o
        • Contact:
      • Brno, Czechia, 61500
        • Recruiting
        • Vojenska nemocnice Brno
        • Contact:
      • Bílovec, Czechia, 743 01
      • Chrudim, Czechia, 537 01
        • Recruiting
        • MUDr. Jan Hubac s.r.o.
        • Contact:
      • Havlíčkův Brod, Czechia, 580 01
        • Recruiting
        • Regional Hospital Havlickuv Brod
        • Contact:
      • Jablonec nad Nisou, Czechia, 46601
        • Recruiting
        • Kardiologie KarMa s.r.o
        • Contact:
      • Jihlava, Czechia, 586 33
        • Not yet recruiting
        • Hospital Jihlava
        • Contact:
      • Litovel, Czechia, 784 01
        • Recruiting
        • MUDr Petra Maskova PhD
        • Contact:
      • Mariánské Lázně, Czechia, 353 01
      • Prague, Czechia, 140 21
        • Recruiting
        • Institute for Clinical and Experimental Medicine
        • Contact:
      • Prague, Czechia, 15006
        • Recruiting
        • University Hospital Motol
        • Contact:
      • Prague, Czechia, 11000
        • Recruiting
        • Kardiologie Vinohrady s r o
        • Contact:
      • Prague, Czechia, 10100
        • Recruiting
        • MUDr. Jan Kvasnicka CSc
        • Contact:
      • Praha 4-Krc, Czechia, 140 59
        • Recruiting
        • University Thomayer´s Hospital
        • Contact:
      • Smiřice, Czechia, 5000
      • Trutnov, Czechia, 541 01
        • Recruiting
        • Kardiologicka ambulance MUDr. Ferkl s.r.o.
        • Contact:
      • Uherské Hradiště, Czechia, 68601
        • Recruiting
        • Clinical Trials Services s.r.o
        • Contact:
      • Uherské Hradiště, Czechia, 68601
        • Not yet recruiting
        • MUDr. Nina Zemkova s.r.o.
        • Contact:
      • Zlín, Czechia, 76001
        • Recruiting
        • Cardio Research s.r.o.
        • Contact:
  • Germany
      • Aachen, Germany, 52074
      • Bad Friedrichshall, Germany, 74177
      • Berlin, Germany, 13353
      • Berlin, Germany, 13407
      • Berlin, Germany, 12203
      • Berlin, Germany, 10789
      • Berlin, Germany, 10787
        • Not yet recruiting
        • Velocity Clinical Research Germany GmbH, Berlin
        • Contact:
      • Berlin, Germany, 13347
      • Berlin, Germany, 13509
      • Bonn, Germany, 53127
      • Dessau, Germany, 06846
      • Dresden, Germany, 01067
      • Dresden, Germany, 01099
        • Not yet recruiting
        • Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
        • Contact:
      • Erfurt, Germany, 99089
      • Frankfurt, Germany, 60590
      • Frankfurt, Germany, 60596
      • Hamburg, Germany, 22143
        • Not yet recruiting
        • Velocity Clinical Research Germany GmbH, Hamburg
        • Contact:
      • Hanover, Germany, 30625
      • Jena, Germany, 07747
      • Kamp-Lintfort, Germany, 47475
      • Kiel, Germany, 24105
        • Not yet recruiting
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel
        • Contact:
      • Langen, Germany, 63225
      • Leipzig, Germany, 04177
        • Not yet recruiting
        • Velocity Clinical Research Germany GmbH, Leipzig
        • Contact:
      • Lüneburg, Germany, 21339
      • Neuwied, Germany, 56564
      • Nuremberg, Germany, 90402
        • Recruiting
        • Gemeinschaftspraxis Dres Haggenmiller/Jeserich
        • Contact:
      • Papenburg, Germany, 26871
      • Regensburg, Germany, 93053
      • Stuhr, Germany, 28816
      • Wallerfing, Germany, 94574
      • Wermsdorf, Germany, 04779
      • Wiesbaden, Germany, 65189
        • Not yet recruiting
        • Velocity Clinical Research Germany GmbH, Wiesbaden
        • Contact:
  • Hungary
      • Baja, Hungary, 6500
        • Recruiting
        • Lausmed Kft. Outpatient Unit of Internal Medicine
        • Contact:
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1096
      • Budapest, Hungary, 1051
      • Budapest, Hungary, 1132
      • Budapest, Hungary, 1152
      • Budapest, Hungary, 1066
      • Budapest, Hungary, 1036
      • Budapest, Hungary, 1134
      • Budapest, Hungary, 1023
        • Recruiting
        • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
        • Contact:
      • Gyula, Hungary, 5700
      • Hatvan, Hungary, 3000
      • Kecskemét, Hungary, 6000
      • Miskolc, Hungary, 3526
        • Recruiting
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
        • Contact:
      • Miskolc, Hungary, 3530
      • Orosháza, Hungary, 5900
      • Pécs, Hungary, 7623
      • Pécs, Hungary, 7624
      • Pécs, Hungary, 7635
      • Szeged, Hungary, 6726
      • Szekszárd, Hungary, 7100
      • Szolnok, Hungary, 5000
        • Recruiting
        • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
        • Contact:
      • Zalaegerszeg, Hungary, 8900
  • India
      • Aurangabad, India, 431 005
        • Recruiting
        • Kamalnayan Bajaj Hospital
        • Contact:
      • Bangalore, India, 560099
        • Not yet recruiting
        • Narayana Institute of Cardiac Sciences
        • Contact:
      • Bengaluru, India, 560002
        • Recruiting
        • Bangalore Medical college
        • Contact:
      • Bikaner, India, 334003
        • Recruiting
        • S.P. Medical College & Associated Group of Hospitals
        • Contact:
      • Chennai, India, 600002
        • Recruiting
        • Tamil Nadu Government Multi Super Speciality Hospital TNGMSSH
        • Contact:
      • Chennai, India, 600006
        • Recruiting
        • Apollo Main Hospital
        • Contact:
      • Gurgaon, India, 122 001
        • Not yet recruiting
        • Medanta-The Medicity
        • Contact:
      • Guwahati, India, 781006
        • Not yet recruiting
        • GNRC Hospital
        • Contact:
      • Kochi, India, 682 018
        • Not yet recruiting
        • Lisie Hospital
        • Contact:
      • Kolkata, India, 700020
        • Recruiting
        • IPGMER and SSKM Hospital
        • Contact:
      • Nashik, India, 422005
        • Not yet recruiting
        • Chopda Medicare and Research Centre Pvt Ltd
        • Contact:
      • New Delhi, India, 110017
        • Recruiting
        • Max Super Speciality Hospital
        • Contact:
      • Surat, India, 395002
        • Recruiting
        • Unicare Heart Institute
        • Contact:
      • Visakhapatnam, India, 530002
        • Recruiting
        • King George Hospital
        • Contact:
  • Italy
      • Bergamo, Italy, 24127
      • Bergamo, Italy, 24125
      • Foggia, Italy, 71122
        • Recruiting
        • Az.Osp. Universitaria "Ospedali Riuniti"
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • Azienda Ospedaliera San Martino
        • Contact:
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria "Federico II"
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
      • Roma, Italy, 00189
        • Recruiting
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
        • Contact:
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
  • Japan
      • Aichi, Kasugai, Japan, 486-8510
        • Recruiting
        • Kasugai Municipal Hospital
        • Contact:
      • Azumino-shi, Japan, 399-8292
        • Recruiting
        • Azumino Red Cross Hospital
        • Contact:
      • Chiba, Chiba, Japan, 263-0043
      • Chūōku, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
      • Fujisawa-shi, Japan, 251-0041
        • Not yet recruiting
        • Shonan Fujisawa Tokushukai Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 802-8555
        • Not yet recruiting
        • Kokura Memorial Hospital
        • Contact:
      • Hamada-shi, Japan, 697-8511
        • Recruiting
        • National Hospital Organization Hamada Medical Center
        • Contact:
      • Higashiibaraki-gun, Japan, 311-3193
        • Recruiting
        • NHO Mito Medical Center
        • Contact:
      • Himeji-shi, Japan, 670-8560
        • Recruiting
        • Hyogo Prefectural Harima-Himeji General Medical Center
        • Contact:
      • Hiratsuka-shi, Japan, 254-8502
        • Not yet recruiting
        • Hiratsuka Kyosai Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 003-0026
        • Recruiting
        • Matsuda Cardiovascular Clinic
        • Contact:
      • Hokkaido, Tomakomai, Japan, 053-8506
      • Hyogo, Amagasaki, Japan, 660-8550
        • Recruiting
        • Hyogo Prefectural Amagasaki General Medical Center
        • Contact:
      • Ishikawa, Kanazawa, Japan, 920-8650
        • Recruiting
        • National Hospital Organization Kanazawa Medical Center
        • Contact:
      • Iwakuni-shi, Japan, 740-8510
        • Recruiting
        • National Hospital Organization Iwakuni Clinical Center
        • Contact:
      • Kamakura-shi, Japan, 247-8533
        • Recruiting
        • Tokushukai Shonan Kamakura General Hospital
        • Contact:
      • Kanagawa, Miura-gun, Japan, 240-0116
        • Recruiting
        • Tokushukai Hayama Heart Center
        • Contact:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Kanagawa, Yokohama, Japan, 247-8581
        • Recruiting
        • Yokohama Sakae Kyosai Hospital
        • Contact:
      • Kanonji-shi, Japan, 769-1695
        • Recruiting
        • Mitoyo General Hospital
        • Contact:
      • Kishiwada-shi, Japan, 596-0042
        • Recruiting
        • Tokushukai Kishiwada Tokushukai Hospital
        • Contact:
      • Kitaazumi-gun, Japan, 399-8695
        • Not yet recruiting
        • North Alps Medical Center Azumi Hospital
        • Contact:
      • Kobe, Japan, 654-0155
        • Recruiting
        • National Hospital Organization Kobe Medical Center
        • Contact:
      • Kumamoto, Japan, 861-8520
        • Not yet recruiting
        • Japanese Red Cross Kumamoto Hospital
        • Contact:
      • Matsumoto-shi, Japan, 390-8621
        • Recruiting
        • Shinshu University Hospital
        • Contact:
      • Matsuyama, Japan, 790-0024
        • Not yet recruiting
        • Ehime Prefectural Central Hospital
        • Contact:
      • Matsuyama, Japan, 790-0067
        • Recruiting
        • Matsuyama Shimin Hospital
        • Contact:
      • Mito, Japan, 311-4198
        • Recruiting
        • Mito Saiseikai General Hospital
        • Contact:
      • Nakano-shi, Japan, 383-8505
        • Recruiting
        • Hokushin General Hospital
        • Contact:
      • Okayama, Okayama, Japan, 700-8557
        • Recruiting
        • Okayama City General Medical Center Okayama City Hospital
        • Contact:
      • Okinawa, Naha, Japan, 902-8511
      • Okinawa, Urasoe, Japan, 901-2102
        • Recruiting
        • Urasoe General Hospital
        • Contact:
      • Osaka, Osaka, Japan, 558-8558
        • Recruiting
        • Osaka General Medical Center
        • Contact:
      • Osaka, Osaka, Japan, 553-0003
        • Recruiting
        • Japan Community Health care Organization Osaka Hospital
        • Contact:
      • Osaka, Osaka, Japan, 550-0006
      • Osaka, Osaka, Japan, 543-8922
        • Recruiting
        • Osaka Keisatsu Hospital
        • Contact:
      • Osaka, Osaka, Japan, 530-8480
      • Saga, Japan, 840-8571
        • Recruiting
        • Saga-Ken Medical Centre Koseikan
        • Contact:
      • Saitama-shi, Japan, 338-0837
      • Saitama-shi, Japan, 331-8577
        • Recruiting
        • Sainokuni Higashiomiya Medical Center
        • Contact:
      • Sendai, Japan, 983-8520
        • Recruiting
        • NHO Sendai Medical Center
        • Contact:
      • Suita-shi, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital
        • Contact:
      • Tachikawa-shi, Japan, 190-8531
        • Not yet recruiting
        • Tachikawa Hospital
        • Contact:
      • Takamatsu, Japan, 760-8557
        • Recruiting
        • Kagawa Prefectural Central Hospital
        • Contact:
      • Tokushima, Japan, 770-8539
        • Recruiting
        • Tokushima Prefectural Central Hospital
        • Contact:
      • Tokyo, Ome, Japan, 198-0042
        • Recruiting
        • Ome Municipal General Hospital
        • Contact:
      • Tomakomai-shi, Japan, 053-8567
        • Recruiting
        • Tomakomai City Hospital
        • Contact:
      • Ōita, Japan, 870-0263
        • Recruiting
        • NHO Oita Medical Center
        • Contact:
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Recruiting
        • Hospital Cardiologica Aguascalientes
        • Contact:
      • Aguascalientes, Mexico, 20230
        • Recruiting
        • Fundación Cardiovascular de Aguascalientes A.C
        • Contact:
      • Culiacán, Mexico, 80230
        • Recruiting
        • Centro Medico Culiacán
        • Contact:
      • Distrito Federal, Mexico, 03100
        • Recruiting
        • Centro de Investigacion Biomedica y Farmaceutica, S.C.
        • Contact:
      • Guadalajara, Mexico, 44670
        • Recruiting
        • CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco S.C.
        • Contact:
      • Guadalajara, Mexico, 45519
      • Irapuato, Mexico, 36520
        • Recruiting
        • Proactive CR Mexico S.A. de C.V.
        • Contact:
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • Monterrey, Mexico, 64060
        • Recruiting
        • Cardiolink Clin Trials S.C.
        • Contact:
      • México, Mexico, 06700
        • Recruiting
        • Clinstile S.A. de C.V.
        • Contact:
      • Tlalnepantla, Mexico, 54055
        • Recruiting
        • Clinical Research Institute S.C.
        • Contact:
      • Torreón, Mexico, 27000
        • Recruiting
        • Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.
        • Contact:
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Recruiting
        • Jeroen Bosch Ziekenhuis-Hertogenbosch
        • Contact:
      • Arnhem, Netherlands, 6815 AD
      • Breda, Netherlands, 4818 CK
      • Deventer, Netherlands, 7416 SE
      • Eindhoven, Netherlands, 5623 EJ
      • Gouda, Netherlands, 2803 HH
      • Leiderdorp, Netherlands, 2353 GA
      • Nieuwegein, Netherlands, 3435 CM
      • Rotterdam, Netherlands, 3083 AN
      • Zaandam, Netherlands, 1502 DV
  • Poland
      • Bialystok, Poland, 15-540
        • Recruiting
        • Univ. Clinic Hosp, Bialystok
        • Contact:
      • Bydgoszcz, Poland, 85231
        • Recruiting
        • NZOZ Medical Center KERmed
        • Contact:
      • Bydgoszcz, Poland, 85-605
        • Recruiting
        • Centrum Medyczne Intercor Sp. z o.o.
        • Contact:
      • Chojnice, Poland, 89-600
        • Not yet recruiting
        • Pratia Chojnice Medical Center
        • Contact:
      • Częstochowa, Poland, 42-217
        • Not yet recruiting
        • Medical Center Pratia Czestochowa
        • Contact:
      • Elblag, Poland, 82-300
        • Not yet recruiting
        • Trevo Clinic Centrum Medyczne
        • Contact:
      • Gdansk, Poland, 80-286
        • Recruiting
        • Poradnia Kardiologiczna Jaroslaw Jurowiecki
        • Contact:
      • Gdynia, Poland, 81-157
        • Recruiting
        • Individual Specialist Medical Practice Krzysztof Cymerman
        • Contact:
      • Katowice, Poland, 40-156
        • Recruiting
        • Clinical Medical Research Sp. z o.o.
        • Contact:
      • Katowice, Poland, 40-081
        • Recruiting
        • Pratia Katowice Medical Center
        • Contact:
      • Kielce, Poland, 25525
        • Not yet recruiting
        • Specialistic Cardiology&Hypertension Out-patient Clin,Kielce
        • Contact:
      • Krakow, Poland, 30-727
        • Not yet recruiting
        • Pratia MCM Krakow
        • Contact:
      • Krakow, Poland, 30-082
        • Recruiting
        • Leszek Bryniarski Specialized Medical Cabinet
        • Contact:
      • Krakow, Poland, 30-721
        • Recruiting
        • Linden Sp. z o.o. sp.k.
        • Contact:
      • Legnica, Poland, 59-220
        • Recruiting
        • Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
        • Contact:
      • Lodz, Poland, 90-302
        • Recruiting
        • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
        • Contact:
      • Lodz, Poland, 94-255
        • Recruiting
        • Individual Specialized Practice
        • Contact:
      • Lowicz, Poland, 99-400
        • Not yet recruiting
        • Lowickie Cardiology Center
        • Contact:
      • Lublin, Poland, 20-601
        • Recruiting
        • Zanamed Medical Clinic Sp. z o.o.
        • Contact:
      • Lublin, Poland, 20-362
        • Recruiting
        • Velocity Nova Sp. z o.o.
        • Contact:
      • Olsztyn, Poland, 10 165
      • Oświęcim, Poland, 32-600
        • Not yet recruiting
        • Medicome Sp. z o.o.
        • Contact:
      • Piaseczno, Poland, 05-500
      • Poznan, Poland, 61-853
        • Recruiting
        • Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners
        • Contact:
      • Ruda Śląska, Poland, 41-710
        • Recruiting
        • Aka-Med Centrum Sp. z o.o. S.K.
        • Contact:
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Centrum Medyczne Medyk
        • Contact:
      • Siedlce, Poland, 08-110
      • Skierniewice, Poland, 96-100
        • Recruiting
        • Velocity Skierniewice Sp. z o.o
        • Contact:
      • Sochaczew, Poland, 96-500
        • Recruiting
        • RCMed- Regionalne Centrum Medyczne
        • Contact:
      • Sopot, Poland, 81-717
        • Recruiting
        • NZOZ Procordis, Cardiology Research Center of Sopot
        • Contact:
      • Staszów, Poland, 28-200
      • Warsaw, Poland, 02-172
        • Not yet recruiting
        • MTZ Clinical Research Powered by Pratia
        • Contact:
      • Warsaw, Poland, 00-215
      • Warsaw, Poland, 01-249
        • Recruiting
        • Balsammedica Sp. z o. o.
        • Contact:
      • Wroclaw, Poland, 50-981
        • Recruiting
        • 4. Military Clinical Hospital with Polyclinic SP ZOZ
        • Contact:
      • Wroclaw, Poland, 53-030
      • Zamość, Poland, 22-400
        • Recruiting
        • KO-MED Clinical Centers Zamosc
        • Contact:
      • Żarów, Poland, 58-130
        • Recruiting
        • Centrum Medyczne Serafin med
        • Contact:
  • Romania
      • Baia Mare, Romania, 430031
        • Not yet recruiting
        • Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare
        • Contact:
      • Baloteşti, Romania, 77015
        • Recruiting
        • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
        • Contact:
      • Brasov, Romania, 500091
        • Recruiting
        • S.C.Centrul Medical Unirea SRL
        • Contact:
      • Brăila, Romania, 810325
        • Recruiting
        • Spitalul Judetean de Urgenta Braila
        • Contact:
      • Bucharest, Romania, 10192
        • Recruiting
        • Clinica Medicala Data Plus SRL
        • Contact:
      • Bucharest, Romania, 050098
        • Recruiting
        • Emergency University Hospital
        • Contact:
      • Bucharesti, Romania, 030463
        • Recruiting
        • S.C. Policlinica CCBR S.R.L.
        • Contact:
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Spitalul Angiocare SRL
        • Contact:
      • Craiova, Romania, 200642
        • Not yet recruiting
        • Emergency County Hospital Craiova
        • Contact:
      • Iași, Romania, 700023
        • Recruiting
        • S.C.Centrul Medical Unirea S.R.L.
        • Contact:
      • Oradea, Romania, 410169
        • Not yet recruiting
        • Spitalul Clinic Judetean de Urgenta Bihor
        • Contact:
      • Piteşti, Romania, 110424
      • Timișoara, Romania, 300362
      • Târgu Mureş, Romania, 540136
        • Not yet recruiting
        • Country Clinical Emergency Hospital, Targu-Mures
        • Contact:
      • Târgu Mureş, Romania, 540136
        • Not yet recruiting
        • Spitalul Clinic Judetean de Urgenta Targu Mures
        • Contact:
      • Târgu Mureş, Romania, 540143
        • Recruiting
        • Podoleanu G. Cristian-Gheorghe-Calin
        • Contact:
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21589
        • Not yet recruiting
        • King AbdulAziz University Hospital
        • Contact:
      • Riyadh, Saudi Arabia, 11211
        • Recruiting
        • King Faisal Specialist Hospital and Research Center
        • Contact:
      • Riyadh, Saudi Arabia, 11426
        • Recruiting
        • King Abdulaziz Medical City
        • Contact:
      • Riyadh, Saudi Arabia, 11525
        • Not yet recruiting
        • King Fahad Medical City
        • Contact:
      • Riyadh, Saudi Arabia, 11623
        • Recruiting
        • King Saud Medical City
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • University Clinical Center of Serbia
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute for Cardiovascular diseases Dedinje
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center " Dr Dragisa Misovic Dedinje"
        • Contact:
      • Belgrade, Serbia, 11080
        • Recruiting
        • Clinical Hospital Center Zemun
        • Contact:
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • Clinical Hospital Center Dr. Dragisa Misovic
        • Contact:
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center of Kragujevac
        • Contact:
      • Niš, Serbia, 18000
        • Recruiting
        • University Clinical Center Niš
        • Contact:
      • Niška Banja, Serbia, 18205
        • Recruiting
        • Institute for Treatment and Rehabilitation, Niska Banja
        • Contact:
      • Pančevo, Serbia, 26000
        • Recruiting
        • General Hospital Pancevo
        • Contact:
      • Smederevo, Serbia, 11300
        • Recruiting
        • General Hospital Sveti Luka
        • Contact:
      • Zaječar, Serbia, 19000
  • Slovenia
      • Celje, Slovenia, 3000
      • Golnik, Slovenia, 4204
      • Jesenice, Slovenia, 4270
      • Ljubljana, Slovenia, 1000
      • Murska Sobota, Slovenia, 9000
      • Trbovlje, Slovenia, 1420
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7500
      • Centurion, South Africa, 0157
      • Centurion, South Africa, 0157
      • Johannesburg, South Africa, 1862
        • Recruiting
        • Chris Hani Baragwanath Hospital: Cardiology Department
        • Contact:
      • Somerset West, South Africa, 7130
      • Worcester, South Africa, 6850
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
      • Busan, South Korea, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Gwangju, South Korea, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
      • Incheon, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
      • Seongnam, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 06351
      • Seoul, South Korea, 03722
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, South Korea, 2841
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
      • Wonju-si, Gangwon State, South Korea, 26426
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
        • Contact:
  • Spain
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08023
      • El Palmar, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
      • Sanlúcar de Barrameda, Spain, 11540
        • Recruiting
        • Hospital Virgen del Camino
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Complexo Hospitalario Universitario De Santiago
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
      • Villamartin, Cardiz, Spain, 11650
        • Recruiting
        • Hospital Virgen de las Montañas
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
      • New Taipei City, Taiwan, 235
        • Not yet recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 404327
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 112
        • Recruiting
        • Cheng Hsin General Hospital
        • Contact:
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 114
        • Not yet recruiting
        • Tri-Service General Hospital
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01330
        • Recruiting
        • Çukurova Ü. Tip Fak., Balcali Hastanesi, Kardiyoloji
        • Contact:
      • Afyonkarahisar, Turkey (Türkiye), 03200
        • Recruiting
        • Afyon Kocatepe University Medical Faculty
        • Contact:
      • Ankara, Turkey (Türkiye), 06170
        • Not yet recruiting
        • Etlik City Hospital
        • Contact:
      • Elâzığ, Turkey (Türkiye), 23119
      • Erzurum, Turkey (Türkiye), 25240
        • Recruiting
        • Ataturk Universitesi Tip Fakultesi
        • Contact:
      • Eskişehir, Turkey (Türkiye), 26480
        • Recruiting
        • Osmangazi Uni Medical Faculty
        • Contact:
      • Gaziantep, Turkey (Türkiye), 27310
        • Recruiting
        • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
        • Contact:
      • Istanbul, Turkey (Türkiye), 34899
        • Not yet recruiting
        • Medical Park Pendik Hospital
        • Contact:
      • Istanbul, Turkey (Türkiye), 34668
        • Not yet recruiting
        • Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
        • Contact:
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara University Pendik Training and Research Hospital
        • Contact:
      • Kütahya, Turkey (Türkiye), 43040
        • Recruiting
        • Kutahya Health Science University
        • Contact:
      • Malatya, Turkey (Türkiye), 44280
        • Recruiting
        • Inonu Universitesi Tip Fakultesi Gogus Hastaliklari ABD
        • Contact:
      • Mersin, Turkey (Türkiye), 33020
        • Recruiting
        • Mersin University Medical Faculty
        • Contact:
      • Trabzon, Turkey (Türkiye), 61080
        • Not yet recruiting
        • KTU Tip Fakultesi Farabi Hastanesi
        • Contact:
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
      • Bristol, United Kingdom, BS10 5NB
      • Exeter, United Kingdom, EX2 5DW
      • Halifax, United Kingdom, HX3 0PW
      • High Wycombe, United Kingdom, HP11 2TT
      • London, United Kingdom, EC1A 7BE
      • Oldham, United Kingdom, OL1 2JH
      • Sheffield, United Kingdom, S5 7AU
      • Truro, United Kingdom, TR1 3LJ
      • York, United Kingdom, YO31 8HE
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
      • Mobile, Alabama, United States, 36604
    • California
      • Chula Vista, California, United States, 91911
      • Orange, California, United States, 92868
      • San Dimas, California, United States, 91773
      • Santa Clarita, California, United States, 91355
      • Tustin, California, United States, 92780
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
    • Florida
      • Boca Raton, Florida, United States, 33434
      • Brandon, Florida, United States, 33511
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular and Interventional Consultants
        • Contact:
      • Daytona Beach, Florida, United States, 32117
      • Gainesville, Florida, United States, 32608
      • Hallandale, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research-Hallandale Beach-67888
        • Contact:
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32209
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • East Coast Institute for Research, LLC - Jacksonville
        • Contact:
      • Largo, Florida, United States, 33777
        • Recruiting
        • Clearwater Cardiovascular Consultants-Largo-69917
        • Contact:
      • Miami, Florida, United States, 33136
      • Miramar Beach, Florida, United States, 32550
        • Active, not recruiting
        • Sacred Heart Medical Specialty Group
      • Naples, Florida, United States, 34102
        • Not yet recruiting
        • Advanced Research for Health Improvement, LLC
        • Contact:
      • Naples, Florida, United States, 34102
      • Ocala, Florida, United States, 34471
      • Ocala, Florida, United States, 34471
      • Port Charlotte, Florida, United States, 33952
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • East Coast Institute for Research, LLC-Saint Augustine-63032
        • Contact:
      • Tampa, Florida, United States, 33612
      • Wellington, Florida, United States, 33449
        • Recruiting
        • Cardiology Partners Clinical Research Institute
        • Contact:
      • Wesley Chapel, Florida, United States, 33544
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Columbus, Georgia, United States, 31904
      • Johns Creek, Georgia, United States, 30024
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
      • Chicago, Illinois, United States, 60657
      • Hazel Crest, Illinois, United States, 60429
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Clinical Investigation Specialists, Inc.-Libertyville-69941
        • Contact:
      • Park Ridge, Illinois, United States, 60068
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Recruiting
        • Midwest Cardiovascular Research and Education Foundation
        • Contact:
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • St. Francis Medical Group-Indiana Heart Physicians, Inc
        • Contact:
      • Merrillville, Indiana, United States, 46410
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Cardiovascular Research of Northwest Indiana, LLC
        • Contact:
      • Richmond, Indiana, United States, 47374
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • West Houston Area Clinical Trial Consultants, LLC
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40205
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
      • Hammond, Louisiana, United States, 70403
      • Shreveport, Louisiana, United States, 71105
      • Slidell, Louisiana, United States, 70458
    • Maryland
      • Baltimore, Maryland, United States, 21229
    • Michigan
      • Dearborn, Michigan, United States, 48126
      • Lansing, Michigan, United States, 48910-0826
      • Southfield, Michigan, United States, 48075
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • Kansas City, Missouri, United States, 64128
      • North Kansas City, Missouri, United States, 64116
      • St Louis, Missouri, United States, 63136
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
      • Manalapan, New Jersey, United States, 07726
      • Somerset, New Jersey, United States, 08873
    • New York
      • New York, New York, United States, 10029
      • New York, New York, United States, 10001
      • The Bronx, New York, United States, 10469
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Marion, Ohio, United States, 43302
      • Toledo, Ohio, United States, 43608
        • Not yet recruiting
        • Mercy Health St. Vincent Medical Center
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Bon Secours Medical Group Greenville Specialty Care, LLC
        • Contact:
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Jackson, Tennessee, United States, 38305
      • Jefferson City, Tennessee, United States, 37760
    • Texas
      • Amarillo, Texas, United States, 79109
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Heart Clinical Research Institute, Incorporated
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
      • Dallas, Texas, United States, 75235
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75231
        • Not yet recruiting
        • Texas Health Research and Education Institute
        • Contact:
      • Fort Worth, Texas, United States, 76104
      • Katy, Texas, United States, 77493
      • Kingwood, Texas, United States, 77339
      • Longview, Texas, United States, 75605
      • McKinney, Texas, United States, 75071
      • McKinney, Texas, United States, 75071
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Manassas, Virginia, United States, 20109
      • Norfolk, Virginia, United States, 23507
      • Winchester, Virginia, United States, 22601
    • Washington
      • Seattle, Washington, United States, 98101
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Care Research Institute and Cardiology Associates
        • Contact:
  • Vietnam
      • Da Nang, Vietnam, 550000
      • Hanoi, Vietnam, 100000
      • Ho Chi Minh City, Vietnam, 700000
      • Ho Chi Minh City, Vietnam, 700000
      • Ho Chi Minh City, Vietnam, 748806
        • Not yet recruiting
        • University Medical Center HCMC
        • Contact:
      • Ho Chi Minh City, Vietnam, 700000
      • Ho Chi Minh City, Vietnam, 70000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
  2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
  4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
  5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2

  6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

    1. in participants with body mass index (BMI) <27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
    2. in participants with BMI ≥27 kg/m² to <35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
    3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)

  7. At least one of the following:

    • Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
    • Documented hospitalisation for HF within 6 months prior to Visit 1

    • Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1

      • in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
      • for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
    • Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
  8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.

Exclusion criteria:

  1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
  2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator

  3. Receiving the following treatments:

    • a direct renin inhibitor (e.g. aliskiren) at Visit 2
    • more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2

    • In case of acute decompensated HF:

      • i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
      • i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
    • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
    • Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
  4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)
  5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
  6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
  7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
  8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
  9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vicadrostat/empagliflozin
Drug: empagliflozin
empagliflozin
Drug: vicadrostat
vicadrostat
Placebo Comparator: placebo/empagliflozin
Drug: empagliflozin
empagliflozin
Drug: placebo
placebo matching vicadrostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Time Frame: up to 42 months
up to 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Time Frame: up to 42 months
up to 42 months
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
Time Frame: at baseline, at week 32

The Kansas City Cardiomyopathy Questionnaire is a patient-reported outcome instrument for use in clinical investigations in heart failure.

The Total Symptom Score measures the following aspects of symptom experience in two domain scores:

The "Symptom Frequency Domain" assesses frequency of the following experiences:

  • Lower extremity swelling in the morning
  • Fatigue limiting patients' ability to do what they want
  • Dyspnea limiting patients' ability to do what they want
  • Dyspnea forcing patients to sleep upright/elevated

The "Symptom Burden Domain" assesses bothersomeness of the following symptoms:

  • Fatigue
  • Dyspnea
  • Lower extremity swelling All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
at baseline, at week 32
Key secondary endpoint: Time to CV death
Time Frame: up to 42 months
up to 42 months
Key secondary endpoint: Time to all-cause mortality
Time Frame: up to 42 months
up to 42 months
Time to first HHF
Time Frame: up to 42 months
up to 42 months
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
Time Frame: at baseline, at week 32

The KCCQ Clinical Summary Score is a composite of the Total Symptom Score and Physical Limitations Score.

The "Physical Limitations Score" measures the following physical limitations:

  • Dressing
  • Showering/bathing
  • Walking one block on level ground
  • Doing yardwork, housework or carrying groceries
  • Climbing a flight of stairs without stopping
  • Hurrying or jogging as if to catch a bus All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
at baseline, at week 32
Absolute change from baseline in KCCQ-TSS at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Key secondary endpoint: Time to first event of CV death or HHF
Time Frame: up to 42 months
up to 42 months
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥50% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)
Time Frame: up to 42 months

* chronic dialysis is defined as dialysis continuing for at least 30 days

** using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)
up to 42 months
Absolute change from baseline in KCCQ-OSS at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥130 mmHg
Time Frame: at baseline, at week 32
at baseline, at week 32
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg
Time Frame: at baseline, at week 32
at baseline, at week 32
Absolute change from baseline in KCCQ-OSS at Week 32
Time Frame: at baseline, at week 32

The Kansas City Cardiomyopathy Questionnaire - overall summary score (KCCQ-OSS) is a combination of the symptom [domain], physical limitations, social limitations, and quality of life domains.

All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
at baseline, at week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

May 22, 2028

Study Completion (Estimated)

May 22, 2028

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1378-0020
  • 2023-509706-30-00 (Registry Identifier: CTIS)
  • U1111-1302-4422 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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