EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

April 26, 2021 updated by: Boehringer Ingelheim

A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3730

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 Locations

  • Argentina
      • Bahia Blanca, Argentina, B8001DDU
        • Hospital Interzonal General de Agudos Dr Jose Penna
      • Bahia Blanca, Argentina, B8001HXM
        • Hospital Italiano Regional del Sur, Bahia Blanca
      • Caba, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Caba, Argentina, C1119ACN
        • CIPREC
      • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
        • CCBR - Buenos Aires - AR
      • Ciudad Autonoma Buenos Aires, Argentina, C1428ART
        • Instituto Cardiovascular de Buenos Aires
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
        • Consultorios Asociados de Endocrinología e Invest Clínica
      • Ciudad Autonoma de Bs As, Argentina, C1120AAC
        • Centro Médico Viamonte
      • Ciudad Autónoma de Bs As, Argentina, C1180AAX
        • Sanatorio Guemes
      • Ciudadela, Argentina, 1702
        • Instituto Medico Elsa Perez SRL (IMEP)
      • Cordoba, Argentina, X5003DCE
        • Instituto Médico DAMIC S.R.L.
      • Cordoba, Argentina, X5002AOQ
        • Clínica Colombo
      • Coronel Suarez, Argentina, B7540DOL
        • Clinica Coronel Suarez SA
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiología de Corrientes
      • Córdoba, Argentina, 5000
        • Sanatorio Mayo Privado SA
      • Córdoba, Argentina, X5000EVQ
        • Centro de Investigaciones Clinicas Instituto del Corazon
      • Córdoba, Argentina, X5000JHQ
        • Sanatorio Allende S.A.
      • Córdoba, Argentina, X5016KEH
        • Hospital Privado
      • La Plata, Argentina, B1900AXI
        • Hospital Italiano de La Plata
      • Mar del Plata, Argentina, B7602CBM
        • Hospital Privado de Comunidad
      • Mar del Plata, Argentina, B7600FYK
        • Centro de Investigaciones Médicas
      • Olivos, Argentina, 1602
        • Clinica Olivos
      • Quilmes, Argentina, B1878DVB
        • Cer Instituto Medico
      • Quilmes, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas de Quilmes
      • Rosario, Argentina, 2000
        • Instituto de Investigaciones Clinicas de Rosario
      • Rosario, Argentina, 2000
        • Instituto Medico Fundación Grupo Colaborativo Rosario
      • Rosario, Argentina, 2000
        • Sanatorio Britanico
      • Rosario, Argentina, 2000
        • Sanatorio Plaza
      • Rosario, Argentina, S2000PBJ
        • Instituto CAICI
      • Rosario, Argentina, S2000DSV
        • Sanatorio Parque
      • Salta, Argentina, A4400ANW
        • CORDIS S.A., Salta
      • Salta, Argentina, A4406BFP
        • Centro Cardiovascular Salta
      • San Martin, Argentina, B1650CSQ
        • Corporacion Medica de Gral. San Martin S.A.
      • San Miguel de Tucumán, Argentina, T4000ICL
        • Investigaciones Clinicas Tucuman
      • San Miguel de Tucumán, Argentina, T4000
        • CCBR Tucuman
      • San Vicente, Argentina, X5006CBI
        • Centro Medico Luquez
      • Santa Fe, Argentina, S3000FWO
        • Centro de investigaciones Clinicas del Litoral
      • Santa Fé, Argentina, S3000EOZ
        • Hospital "Dr. José Maria Cullen "
      • Tucumán, Argentina, T4000JCU
        • Instituto de Cardiología
      • Villa Luro, Argentina, C1440CFD
        • CEMEDIC - Centro de Especialidades Medicas
  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Hospital
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Core Research Group
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • SA-Heart Ashford Specialist Centre
      • Fullarton, South Australia, Australia, 5063
        • Heart and Vascular Research
    • Victoria
      • Epping, Victoria, Australia, 3076
        • The Northern Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Geelong, Victoria, Australia, 3220
        • University Hospital Geelong
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Belgium
      • Brugge, Belgium, 3000
        • AZ Sint-Jan Brugge
      • Charleroi, Belgium, 6000
        • C.H.U. de Charleroi
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg - Campus Sint-Jan
      • Gent, Belgium, 9000
        • AZ Sint-Lucas - Campus Sint Lucas
      • Gilly, Belgium, 6060
        • Grand Hopital de Charleroi
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis - Campus Virga Jesse
      • La Louvière, Belgium, 7100
        • La Louvière - UNIV CHU Tivoli
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Mechelen, Belgium, 2800
        • AZ Sint-Maarten
  • Brazil
      • Belo Horizonte, Brazil, 30110-060
        • Hospital Felicio Rocho
      • Belo Horizonte, Brazil, 30140-062
        • Hospital Vera Cruz
      • Belo Horizonte, Brazil, 30150-240
        • Cardresearch Cardiologia Assistencial e de Pesquisas Ltda
      • Brasília, Brazil, 70673-900
        • ICDF - Instituto de Cardiologia do Distrito Federal
      • Brasília, Brazil, 70710-100
        • CECAP - Centro de Cardiologia Clínica
      • Brasília, Brazil, 70200-730
        • CCBR - Brasilia
      • Campina Grande do Sul, Brazil, 83430-000
        • Hospital Angelina Caron
      • Campinas, Brazil, 13010-001
        • Centro Especializado em Cardiol Loema Instituto de Pesq Clin
      • Campinas, Brazil, 13060-080
        • IPECC - Instituto de Pesquisa Clínica de Campinas
      • Campinas, Brazil, 13087-567
        • CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas
      • Canoas, Brazil, 92425-900
        • Hospital Universitario
      • Caxias do Sul, Brazil, 95070-560
        • IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul
      • Curitiba, Brazil, 80230-130
        • Irmandade da Santa Casa de Misericordia de Curitiba
      • Fortaleza, Brazil, 60846-190
        • Hospital de Messejana Dr. Carlos Alberto Studart Gomes
      • Goiania, Brazil, 74223-130
        • Barroso e Sebba Ltda
      • Goiânia, Brazil, 74605-020
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
      • Marília, Brazil, 17515-000
        • ICM - Instituto do Coração de Marília
      • Passo Fundo, Brazil, 99010-080
        • Hospital São Vicente de Paulo
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Brazil, 90035-074
        • Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil, 90035-170
        • Centro de Pesquisas em Diabetes
      • Porto Alegre, Brazil, 90620-001
        • Instituto de Cardiologia Rio Grande do Sul
      • Recife, Brazil, 52051-380
        • Hospital Agamenon Magalhaes
      • Ribeirão Preto, Brazil, 14048-900
        • H.C.da Fac. de Medicina de Ribeirao Preto
      • Rio De Janeiro - RJ, Brazil, CEP 20551
        • Hospital Universitário Pedro Ernesto UERJ
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR - Rio de Janeiro - BR
      • Santo André, Brazil, 09090-790
        • Praxis Pesquisa Medica
      • Santo André, Brazil, 09080-110
        • Pesquisare
      • Sao Jose do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina, Sao Jose
      • Sao Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
      • Sao Paulo, Brazil, 05403-000
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
      • Sao Paulo, Brazil, 01244-030
        • Centro de Pesquisa Clinica - CPCLIN
      • Sao Paulo, Brazil, 01323-000
        • FGM - Clínica Paulista de Doenças Cardiovasculares
      • São Bernardo do Campo, Brazil, 09780-000
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São Paulo, Brazil, 04020-060
        • CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil
      • São Paulo, Brazil, 04208-002
        • Dr. Consulta
      • Vitória, Brazil, 29055-450
        • CEDOES - Diagnóstico e Pesquisa,Vitória
      • Votuporanga, Brazil, 15500-003
        • Santa Casa de Votuporanga
  • Canada
      • Quebec, Canada, G1V 4G5
        • IUCPQ (Laval University)
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G.A. Research Associates Ltd
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre
    • Ontario
      • Brampton, Ontario, Canada, L6W 2X7
        • Brampton Cardio Pulmonary Clinic
      • Burlington, Ontario, Canada, L7M 4Y1
        • JBN Medical Diagnostic Services Inc.
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Inc.
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8L 0A9
        • Curnew Medicine Professional Corporation
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Southlake Regional Health Centre
      • Oakville, Ontario, Canada, L6K 3W7
        • M Heffernan Medicine Professional Corp.
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
      • Scarborough, Ontario, Canada, M1E 5E9
        • Scarborough Cardiology Research
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Heart Health Institute
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Toronto, Ontario, Canada, M3J 2C5
        • Canadian Phase Onward Inc.
      • Toronto, Ontario, Canada, M6G 1M2
        • Diabetes Heart Research Centre
      • Toronto, Ontario, Canada, M6B 1N6
        • North York Diagnostic and Cardiac Centre
      • Waterloo, Ontario, Canada, N2T 0C1
        • Mohan Babapulle Medicine Professional Medicine
      • York, Ontario, Canada, M9N 1W4
        • Dr. Louis C.H. Yao
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • ViaCar Recherche Clinique Inc
      • Longeuil, Quebec, Canada, J4M 2X1
        • Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Centre
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H1T 3Y7
        • Clinique Sante Cardio MC
      • Saint George-de-Beauce, Quebec, Canada, G5Y 4T8
        • Centre de sante et de services sociaux de Beauce
  • China
      • Beijing, China, 100037
        • Cardiovascular Institute and Fu Wai Hospital
      • Beijing, China, 100050
        • Beijing Friendship Hospital
      • Changchun, China, 130021
        • First Hospital of Jilin University
      • Changsha, China, 410005
        • Hunan Provincial People's Hospital
      • Changsha, China, 410011
        • 2nd Xiangya Hospital of Central South University
      • Changsha, China, 410015
        • The Third Hospital of Changsha
      • Dongguan, China, 523059
        • Dongguan People's Hospital
      • Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China, 510180
        • Guangzhou First Municipal People's Hospital
      • Guangzhou, China, 510080
        • The First Afiliated Hospital, Sun Yet-sen University
      • Haikou, China, 570311
        • Hainan Provincial People's Hospital
      • Haikou, China, 570208
        • Haikou People's Hospital
      • Lanzhou, China, 730000
        • The First Affiliated Hospital of Lanzhou University
      • Lanzhou, China, 730030
        • The Second Affiliated Hospital of Lanzhou Medical University
      • Luzhou, China, 646099
        • The Affiliated Hospital Of Southwest Medical University
      • Nanchang, China, 330008
        • Nanchang University Affiliated 3rd Hospital
      • Nanjing, China, 210029
        • First Hospital Affiliated with Nanjing Medical University
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
      • Shenyang, China, 110072
        • Shengjing Hospital Of China Medical University
      • Shenyang, China, 110015
        • General Hospital of Shenyang Military Region
      • Tianjin, China, 300121
        • Tianjin Union Medical Center Nankai University Affiliated Hospital
      • Wuhan, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, China, 430030
        • Tongji Hospital, Tongji University
      • Xi'an, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University
      • Yanji, China, 133000
        • Yanbian University Hospital
      • Yueyang, China, 414000
        • the first people hospital of Yue Yang
      • Zhenjiang, China, 212013
        • Affiliated Hospital of Jiangsu University
  • Czechia
      • Bilovec, Czechia, 74301
        • Poliklinika Humanitas
      • Brandys Nad, Czechia, 250 01
        • Medicus Services Ltd.
      • Brno, Czechia, 63600
        • Vojenska nemocnice Brno
      • Brno, Czechia, 603 00
        • Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno
      • Brno, Czechia, 615 00
        • MUDr. Alexandra Ludkova
      • Brno, Czechia, 63900
        • Nemocnice Milosrdnych bratri
      • Broumov, Czechia, 55001
        • EDUMED s.r.o
      • Chrudim, Czechia, 53702
        • MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance
      • Frydek-Mistek, Czechia, 73818
        • Nemocnice ve Frydku-Mistku, prispevkova organizace
      • Louny, Czechia, 440 01
        • MUDr. Ladislav Busak
      • Olomouc, Czechia, 779 00
        • Zdenek Vomacka
      • Pardubice, Czechia, 53002
        • PV-Kardiologie s.r.o.
      • Prag 5, Czechia, 15006
        • University Hospital Motol
      • Prague 2, Czechia, 128 08
        • General Faculty Hospital, Prague
      • Praha 4 - Krc, Czechia, 140 59
        • Thomayer Hospital
      • Prerov, Czechia, 75000
        • Kardio Vaclavik s.r.o.
      • Pribram, Czechia, 261 01
        • Clinic of Cardiology, Pribram
      • Trebic, Czechia, 67401
        • Hospital Trebic, p.o.
      • Usti nad Labem, Czechia, 40113
        • Masaryk Hospital, Usti nad Labem
      • Zlin, Czechia, 76001
        • Angiocor s.r.o
      • Znojmo, Czechia, 66902
        • KIGE s.r.o
  • France
      • Bayonne, France, 64100
        • HOP de Bayonne
      • Besançon, France, 25030
        • HOP Jean Minjoz
      • Bron, France, 69500
        • HOP Louis Pradel
      • Caen, France, 14033
        • HOP Côte de Nacre
      • Montpellier, France, 34295
        • HOP Arnaud de Villeneuve
      • Paris, France, 75651
        • HOP La Pitié Salpêtrière
      • Pau, France, 64046
        • Centre Hospitalier de Pau
      • Pessac, France, 33600
        • HOP Haut-Lévêque
      • Toulouse, France, 31059
        • HOP Rangueil
      • Vandoeuvre-lès-Nancy, France, 54511
        • INS Louis Mathieu
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen, AöR
      • Berlin, Germany, 12351
        • Vivantes Netzwerk für Gesundheit GmbH
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 12200
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10789
        • Praxis Dr. Rieker, Berlin
      • Bielefeld, Germany, 33604
        • Klinikum Bielefeld gGmbH
      • Dessau-Roßlau, Germany, 06846
        • Praxis Dr. Menzel
      • Dortmund, Germany, 44137
        • St. Johannes Hospital Dortmund
      • Dresden, Germany, 01307
        • GWT-TUD GmbH
      • Dresden, Germany, 01067
        • Städtisches Klinikum Dresden
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Essen, Germany, 45355
        • Studienzentrum Bocholderstrasse
      • Frankfurt, Germany, 60594
        • ClinPhenomics GmbH & Co KG, Frankfurt
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen, Georg-August-Universität
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Jena, Germany, 07740
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Langen, Germany, 63225
        • Asklepios Klinik Langen-Seligenstadt GmbH
      • Lüdenscheid, Germany, 58515
        • Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
      • Lüneburg, Germany, 21339
        • Praxis Dr. Sarnighausen, Lüneburg
      • Mainz, Germany, 55131
        • Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz
      • München, Germany, 80636
        • Deutsches Herzzentrum München
      • Nienburg, Germany, 31582
        • Kardiologische Gemeinschaftspraxis Nienburg
      • Papenburg, Germany, 26871
        • Kardiologische Praxis Papenburg
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Riesa, Germany, 01587
        • Praxis Dr. Stenzel, Riesa
      • Wangen, Germany, 88239
        • Zentrum für klinische Forschung
      • Warendorf, Germany, 48231
        • Josephs-Hospital Warendorf
      • Wuppertal, Germany, 42283
        • Petrus-Krankenhaus
  • Hungary
      • Baja, Hungary, 6500
        • Lausmed Kft. Outpatient Unit of Internal Medicine
      • Bekescsaba, Hungary, 5600
        • Belgyogyaszati es Kardiologiai Maganrendelo
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1122
        • Semmelweis University
      • Budapest, Hungary, 1106
        • Bajcsy-Zsilinszky Hospital and Clinic
      • Budapest, Hungary, 1134
        • Milit.Hosp.-State Health Cent.
      • Budapest, Hungary, 1145
        • Uzsoki Street Hospital, Budapest
      • Budapest, Hungary, 1096
        • Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
      • Debrecen, Hungary, 4027
        • Nehezlegzes Ambulancia
      • Gyongyos, Hungary, 3200
        • Bugat Pal Hospital, Gyongyos
      • Komarom, Hungary, 2900
        • Selye Janos Hospital Komarom
      • Nagykanizsa, Hungary, 8800
        • Dorottya Kanizsai Hospital
      • Oroshaza, Hungary, 5900
        • Dr. Nagy Laszlo Kardiologiai Maganrendeles
      • Pecs, Hungary, 7635
        • Da Vinci Maganklinika
      • Pécs, Hungary, 7623
        • Pecsi Tudomanyegyetem
      • Szekesfehervar, Hungary, 8000
        • Fejer County Saint George University Teaching Hospital
      • Veszprem, Hungary, 8200
        • Veszpremi Sziv es Egeszseg Centrum
  • India
      • Ahmedabad, India, 380007
        • Doctor Jivraj Mehta Smarak Health Foundation
      • Aurangabad, India, 431 005
        • Kamalnayan Bajaj Hospital
      • Bangalore, India, 560099
        • Narayana Institute of Cardiac Sciences
      • Bengaluru, India, 560074
        • Rajarajeswari Medical College
      • Chennai, India, 600035
        • Apollo Speciality Hospital
      • Chennai, India, 600 037
        • Madras Medical Mission,
      • Gurgaon, India, 122001
        • Medanta-The Medicity
      • Kolkatta, India, 700027
        • B.M. Birla Heart research Centre
      • Nashik, India, 422007
        • Siddhi Hospital
      • Nasik, India, 422005
        • Vijan Cardiac and Critical Care Centre
      • New Delhi, India, 110060
        • Sir Gangaram Hospital
      • New Delhi, India, 110002
        • GB Pant Hospital
      • New Delhi, India, 110025
        • Fortis Escorts Heart Institute
      • New Delhi, India, 110 062
        • Batra Hospital and Medical Research Centre
  • Italy
      • Benevento, Italy, 82100
        • Azienda Ospedaliera G. Rummo
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
      • Cona (FE), Italy, 44124
        • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
      • Cortona (AR), Italy, 52040
        • Ospedale della Val di Chiana Santa Margherita
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino-IRCCS
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
      • Roma, Italy, 00161
        • Umberto I Pol. di Roma-Università di Roma La Sapienza
      • Trieste, Italy, 34128
        • Azienda Servizi Sanitari 1 Triestina
  • Japan
      • Aichi, Kasugai, Japan, 486-8510
        • Kasugai Municipal Hospital
      • Aichi, Nagoya, Japan, 466-8650
        • Japanese Red Cross Nagoya Daini Hospital
      • Aichi, Nagoya, Japan, 454-0933
        • Nagoya Kyoritsu Hospital
      • Aichi, Toyota, Japan, 471-8513
        • Toyota Memorial Hospital
      • Chiba, Chiba, Japan, 263-0043
        • Chiba Heart Clinic
      • Chiba, Kisarazu, Japan, 292-8535
        • Kimitsu Chuo Hospital
      • Chiba, Matsudo, Japan, 271-0077
        • Seikeikai New Tokyo Heart Clinic
      • Ehime, Matsuyama, Japan, 790-0024
        • Ehime Prefectural Central Hospital
      • Ehime, Matsuyama, Japan, 790-0067
        • Matsuyama Shimin Hospital
      • Ehime, Uwajima, Japan, 798-8510
        • Uwajima City Hospital
      • Fukui, Fukui, Japan, 918-8503
        • Fukuiken Saiseikai Hospital
      • Fukuoka, Chikushino, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Chikushino, Japan, 818-8516
        • Fukuokaken Saiseikai Futsukaichi Hospital
      • Fukuoka, Fukuoka, Japan, 810-0001
        • Saiseikai Fukuoka General Hospital
      • Fukuoka, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Iizuka, Japan, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Fukuoka, Kitakyushu, Japan, 806-8501
        • Japan Community Health Care Organization Kyushu Hospital
      • Fukuoka, Kitakyushu, Japan, 805-8508
        • Steel Memorial Yawata Hospital
      • Gifu, Ogaki, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Gifu, Seki, Japan, 501-3802
        • Chuno Kosei Hospital
      • Hiroshima, Fukuyama, Japan, 721-8511
        • Fukuyama City Hospital
      • Hiroshima, Hatsukaichi, Japan, 738-8503
        • JA Hiroshima General Hospital
      • Hiroshima, Shobara, Japan, 727-0013
        • Shobara Red Cross Hospital
      • Hokkaido, Hakodate, Japan, 041-8512
        • National Hospital Organization Hakodate Hospital
      • Hokkaido, Sapporo, Japan, 006-0811
        • Teine Keijinkai Clinic
      • Hokkaido, Tomakomai, Japan, 053-8567
        • Tomakomai City Hospital
      • Hyogo, Amagasaki, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Hyogo, Himeji, Japan, 670-0981
        • Hyogo Brain and Heart Center
      • Hyogo, Kobe, Japan, 654-0155
        • National Hospital Organization Kobe Medical Center
      • Ibaraki, Higashiibaraki-gun, Japan, 311-3193
        • Mito Medical Center
      • Ishikawa, Kanazawa, Japan, 920-8650
        • National Hospital Organization Kanazawa Medical Center
      • Kagawa, Kanonji, Japan, 769-1695
        • Mitoyo General Hospital
      • Kagawa, Takamatsu, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Kanagawa, Sagamihara, Japan, 252-0311
        • Yamamoto Clinic
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Kumamoto, Kumamoto, Japan, 861-8520
        • Japanese Red Cross Kumamoto Hospital
      • Kumamoto, Kumamoto, Japan, 862-0950
        • Seiwakai Suizenji Touya Hospital
      • Kumamoto, Yatsushiro, Japan, 866-8533
        • Kumamoto Rosai Hospital
      • Kyoto, Uji, Japan, 611-0041
        • Uji-Tokushukai Medical Center
      • Miyagi, Sendai, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
      • Miyagi, Sendai, Japan, 980-0873
        • Sendai Kousei Hospital
      • Miyagi, Sendai, Japan, 981-3131
        • Sendai Tokushukai Hospital
      • Miyagi, Sendai, Japan, 981-3133
        • The Cardiovascular Center of Sendai
      • Miyazaki, Miyazaki, Japan, 880-0834
        • Miyazaki Medical Association Hospital
      • Nagano, Nakano, Japan, 383-8505
        • Hokushin General Hospital
      • Nagasaki, Omura, Japan, 856-8562
        • Nagasaki Medical Center
      • Okayama, Okayama, Japan, 700-8557
        • Okayama City General Medical Center
      • Okinawa, Naha, Japan, 902-8511
        • Naha City Hospital
      • Okinawa, Shimajiri-gun, Japan, 901-0493
        • Nanbu Tokushukai Hospital
      • Okinawa, Urasoe, Japan, 901-2132
        • Urasoe General Hospital
      • Osaka, Higashiosaka, Japan, 578-8588
        • Higashiosaka City Medical Center
      • Osaka, Osaka, Japan, 530-8480
        • Kitano Hospital
      • Osaka, Osaka, Japan, 533-0024
        • Yodogawa Christian Hospital
      • Osaka, Sakai, Japan, 599-8247
        • Seichokai Bell Land General Hospital
      • Osaka, Takatsuki, Japan, 569-8585
        • Hokusetsu General Hospital
      • Saitama, Saitama, Japan, 338-0837
        • San-Ai Hospital
      • Saitama, Saitama, Japan, 339-0033
        • Kosekai Iwatsuki-minami Hospital
      • Shiga, Kusatsu, Japan, 525-8585
        • Kusatsu General Hospital
      • Tokushima, Tokushima, Japan, 770-8539
        • Tokushima Prefectural Central Hospital
      • Tokyo, Meguro-ku, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
      • Tokyo, Ome, Japan, 198-0042
        • Ome Municipal General Hospital
      • Tokyo, Ota-ku, Japan, 143-0013
        • Tokyo Rosai Hospital
      • Tokyo, Toshima-ku, Japan, 171-0014
        • Sekino Hospital
      • Wakayama, Tanabe, Japan, 646-8558
        • Minami Wakayama Medical Center
      • Yamaguchi, Shimonoseki, Japan, 752-8510
        • Kanmon Medical Center
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Cheongju, Korea, Republic of, 361-771
        • Chungbuk National University Hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Sungnam, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hosp
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiológica Aguascalientes
      • Ciudad de Mexico, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • Distrito Federal, Mexico, 03100
        • Centro de Investigacion Biomedica y Farmaceutica, S.C.
      • Guadalajara, Mexico, 44150
        • Unidad de Investigacion Clinica Cardiometabolica de Occident
      • Guadalajara, Mexico, 44670
        • Cardiologia Clinica e Intervencionista
      • Guadalajara, Mexico, 44656
        • Diseño y Planeación en Investigación Médica SC
      • Mexico, Mexico, 07020
        • Centro de Investigación Clinica Acelerada, S.C.
      • Monclova, Mexico, 25750
        • Instituto Cardiovascular de Monclova, S de RL de CV
      • México, Mexico, 11650
        • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
      • Nuevo Leon, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • San Juan del Rio, Mexico, 76800
        • Centro Integral Medico SJR S.C.
      • San Luis Potosi, Mexico, 78213
        • Cardioarritmias e Investigación S.C
      • Tijuana, Mexico, 22500
        • Centro de Investigacion Cardiovascular y Metabólica
      • Torreon, Mexico, 27000
        • Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.
      • Zapopan, Mexico, 45200
        • Hospital Dr Angel Leano
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Ziekenhuisgroep Twente locatie Almelo
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC, Locatie AMC
      • Amsterdam, Netherlands, 1034 CS
        • BovenIJ Ziekenhuis
      • Amsterdam, Netherlands, 1081HV
        • Amsterdam UMC locatie VUMC
      • Amsterdam, Netherlands, 1061 AE
        • Onze Lieve Vrouwe Gasthuis, Locatie West
      • Amsterdam, Netherlands, 1091AC
        • Onze Lieve Vrouwe Gasthuis
      • Beverwijk, Netherlands, 1942 LE
        • Rode Kruis Ziekenhuis Beverwijk
      • Blaricum, Netherlands, 1261 AN
        • Tergooiziekenhuizen locatie Blaricum
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis
      • Den Haag, Netherlands, 2597 AX
        • HMC Bronovo
      • EDE, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Heerlen, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum
      • Hoorn, Netherlands, 1624 NP
        • Vasculair Onderzoek Centrum
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum
      • Meppel, Netherlands, 7943 KA
        • Diaconessenhuis Meppel
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius ziekenhuis, locatie Nieuwegein
      • Nijmegen, Netherlands, 6525 GL
        • Radboud Universitair Medisch Centrum
      • Uden, Netherlands, 5406 PT
        • Ziekenhuis Bernhoven Uden
      • Venlo, Netherlands, 5912 BL
        • Vie Curi Medisch Centrum
      • Zaandam, Netherlands, 1502 DV
        • De Heel - Zaans Medisch Centrum
      • Zutphen, Netherlands, 7207 AE
        • Gelre Ziekenhuis Zutphen
  • Poland
      • Bialystok, Poland, 15-765
        • KLIMED Marek Klimkiewicz
      • Bialystok, Poland, 15276
        • Univ. Clinic Hosp, Bialystok
      • Bielsko-Biala, Poland, 43-316
        • American Heart of Poland Sp. z o.o.
      • Bydgoszcz, Poland, 85231
        • NZOZ Centrum Medyczne KERmed
      • Chorzow, Poland, 32-500
        • Polsko-Amerykańskie Kliniki Serca
      • Dabrowa Gornicza, Poland, 41-300
        • American Heart of Poland Sp. z o.o.
      • Gdansk, Poland, 80952
        • University Clinical Center, Gdansk
      • Gdansk, Poland, 80-286
        • Poradnia Kardiologiczna Jaroslaw Jurowiecki
      • Gdynia, Poland, 81348
        • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
      • Gdynia, Poland, 81-157
        • Indywidualna Specjalistyczna Praktyka Lekarska
      • Katowice, Poland, 40-211
        • Szpital Zakonu Bonifratow Sp. z o.o.
      • Kielce, Poland, 25525
        • Specialistic Cardiology&Hypertension Out-patient Clin,Kielce
      • Krakow, Poland, 30-082
        • Leszek Bryniarski Specialized Medical Cabinet
      • Krakow, Poland, 31-202
        • Krakow Specialistic Hospital of John Paul II
      • Lodz, Poland, 90-302
        • Santa Familia Centrum Badan, Profilaktyki I Leczenia
      • Lodz, Poland, 94-255
        • Individual Specialized Practice
      • Lodz, Poland, 91-302
        • Nzoz Salus
      • Lowicz, Poland, 99-400
        • Lowickie Cardiology Center
      • Nysa, Poland, 48-300
        • American Heart of Poland Sp. z o.o.
      • Oswiecim, Poland, 32-600
        • MEDICOME Sp. z o.o.
      • Ruda Slaska, Poland, 41-709
        • Specialized Practice Dr. Janusz Spyra
      • Rzeszow, Poland, 35-055
        • Centrum Medyczne MEDYK
      • Siedlce, Poland, 08-110
        • Lukmed Lukasz Wozniak
      • Skierniewice, Poland, 96-100
        • Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice
      • Staszow, Poland, 28-200
        • Ko-Med Centra Kliniczne Staszow
      • Torun, Poland, 87-100
        • The Provincial Polyclinical Hospital in Torun
      • Tychy, Poland, 43-100
        • American Heart of Poland Sp. z o.o.
      • Ustron, Poland, 43-450
        • American Heart of Poland Sp. z o.o.
      • Warsaw, Poland, 02-097
        • Central Hospital of Medical Academy, Warsaw
      • Warszawa, Poland, 02-777
        • McM Polimedica
      • Wroclaw, Poland, 50-981
        • 4. Military Clinical Hospital with Polyclinic SP ZOZ
      • Zgierz, Poland, 95-100
        • Zgierskie Center of Cardiology MED-PRO
      • Zychlin, Poland, 62-571
        • Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"
  • Spain
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08023
        • Hospital Quiron. I.C.U.
      • El Palmar, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital de Bellvitge
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Orense, Spain, 32005
        • Complejo Hospitalario Universitario de Orense
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico De Santiago
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Barnet General Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Eastleigh, United Kingdom, SO53 4ST
        • Park & St Francis Surgery
      • High Wycombe, United Kingdom, HP11 2TT
        • Wycombe General Hospital
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Luton, United Kingdom, LU4 0DZ
        • Luton and Dunstable University Hospital
      • Newport, United Kingdom, PO30 5TG
        • St Mary's Hospital
      • Swansea, United Kingdom, SA6 6NL
        • Morriston Hospital
  • United States
    • California
      • La Mesa, California, United States, 91942
        • La Mesa Cardiac Center
      • Long Beach, California, United States, 90807
        • Long Beach Center For Clinical Research
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Merced, California, United States, 95340
        • Merced Vein and Vascular Center
      • Orange, California, United States, 92865
        • University of California Irvine
      • Riverside, California, United States, 92506
        • Covigilant Research, LLC
      • Torrance, California, United States, 90502
        • University of California
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • Vista, California, United States, 92083
        • Blue Coast Cardiology
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates, PC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Integrated Heart Care
      • Clearwater, Florida, United States, 33756
        • Morton Plant Mease Health Care
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Fort Lauderdale, Florida, United States, 33312
        • Integrative Research Associates
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
      • Miami, Florida, United States, 33173
        • Cardiovascular Research Center of South Florida
      • Ormond Beach, Florida, United States, 32174
        • Peninsula Research, Inc.
      • Pensacola, Florida, United States, 32501
        • Cardiology Consultants, Inc
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Clinical Research Center
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Lawrenceville, Georgia, United States, 30046
        • Cardiovascular Group PC
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research, LLC
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • North Chicago, Illinois, United States, 60064
        • Captain James A. Lovell Federal Health Care Center
      • Rockford, Illinois, United States, 61107
        • Rockford CardioVascular Associates
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Midwest Cardiovascular Research and Education Foundation
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Medical Group-Indiana Heart Physicians, Inc
      • Richmond, Indiana, United States, 47374
        • Reid Hospital
      • South Bend, Indiana, United States, 46601
        • Beacon Medical Group Clinical Research
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Covington, Louisiana, United States, 70433
        • Louisiana Heart Center
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital and Clinic
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21237
        • MedStar Health Research Institute
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University Hospital School of Medicine
      • Beltsville, Maryland, United States, 20705
        • Metropolitan Cardiovascular Consultants
      • Towson, Maryland, United States, 21204
        • Spectrum Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Great Barrington, Massachusetts, United States, 01230
        • East Mountain Medical Associates, PC
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Alpena General Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63136
        • SLHV
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Advanced Heart Care, LLC
    • New York
      • Bronx, New York, United States, 10469
        • Cardiac Care and Vascular Medicine, PLLC
      • Cheektowaga, New York, United States, 14227
        • Trinity Medical WNY, PC
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • Lake Success, New York, United States, 11041
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10035
        • Harlem Cardiology
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clinic West
      • Chapel Hill, North Carolina, United States, 27599-5021
        • The University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Institute
      • Durham, North Carolina, United States, 27609
        • Duke University Medical Center
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia
      • Lenoir, North Carolina, United States, 28645
        • Clinical Trials of America, Inc
    • Ohio
      • Marion, Ohio, United States, 43302
        • Rama Research LLC
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research Group
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Cardiology
      • York, Pennsylvania, United States, 17403
        • York Hospital, WellSpan Health
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Clinical Research
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health
      • Columbia, South Carolina, United States, 29209
        • William Jennings Bryan Dorn VA Medical Center
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29302
        • Palmetto Research Center, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart and Vascular Hospital
      • Dallas, Texas, United States, 75226
        • Soltero Cardiovascular Research Center
      • Dallas, Texas, United States, 75390-8837
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Plano, Texas, United States, 75093
        • The Heart Hospital
    • Utah
      • Farmington, Utah, United States, 84025
        • Alpine Research Organization
    • Virginia
      • Chester, Virginia, United States, 23836
        • Cardiac Health Management Network, P.C.
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center
      • Roanoke, Virginia, United States, 24014
        • Roanoke Heart Institute PLC
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening

  • Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

    • If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
    • If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
    • If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
    • EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
  • Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
  • Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
  • Signed and dated written ICF (Informed Consent Form)
  • Further inclusion criteria apply

Exclusion criteria:

  • Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
  • Heart transplant recipient, or listed for heart transplant
  • Acute decompensated HF
  • Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
  • Symptomatic hypotension and/or a SBP < 100 mmHg
  • Indication of liver disease
  • Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
  • History of ketoacidosis
  • Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
  • Currently enrolled in another investigational device or drug study
  • Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
  • 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
once daily
EXPERIMENTAL: Empagliflozin
Drug: Empagliflozin
once daily
Other Names:
  • JARDIANCE, JARDIANZ, GIBTULIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)
Time Frame: From randomisation until completion of the planned treatment phase, up to 1040 days.

Reported is the total number of HHF events (first and recurrent) which occurred.

All data up to the end of the planned treatment period (including the data after the end of treatment for patients not completing the treatment period as planned) from all randomised patients was used.
From randomisation until completion of the planned treatment phase, up to 1040 days.
eGFR (CKD-EPI) cr Slope of Change From Baseline
Time Frame: Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.

Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) [mL/min/1.73m2] slope of change from baseline.

Available on-treatment change-from-baseline data were to be used. Patients without on-treatment data after randomisation were not to be included in this analysis. Slope represents the long term effect on eGFR.

Timepoints after baseline were included in calculation of slope of change from baseline. Descriptive statistic (mean(standard error)) is reported.
Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.
Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to the first event in the composite renal endpoint: chronic dialysis (with a frequency of twice per week or more for at least 90 days), renal transplant, or sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr).

The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.
Time to First Adjudicated Hospitalisation for Heart Failure (HHF)
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to first adjudicated Hospitalisation for Heart Failure (HHF). The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.
Time to Adjudicated Cardiovascular (CV) Death
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to adjudicated CV (Cardiovascular) death. The incidence rate (patients with events per 100 person years at risk) is reported.

The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.
Time to All-cause Mortality
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to all-cause mortality. The incidence rate (patients with events per 100 person years at risk) is reported.

The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.
Time to Onset of Diabetes Mellitus (DM)
Time Frame: From randomisation until completion of the planned treatment period, up to 1040 days.

Time to onset of DM (Glycated haemoglobin (HbA1c) ≥6.5% or as diagnosed by the investigator) in patients with pre-DM (no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of 5.7 to <6.5%). The incidence rate (patients with events per 100 person years at risk) is reported.

The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25.

Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.

Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
From randomisation until completion of the planned treatment period, up to 1040 days.
Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52
Time Frame: Assessed at baseline, week 12, week 32 and week 52.

Change from baseline in KCCQ (Kansas City cardiomyopathy questionnaire) clinical summary score at Week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death.

Standard error is adjusted standard error. Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.
Assessed at baseline, week 12, week 32 and week 52.
Number of All-cause Hospitalizations (First and Recurrent)
Time Frame: From randomisation until completion of the planned treatment phase, up to 1040 days.
Number of all-cause hospitalizations (first and recurrent).
From randomisation until completion of the planned treatment phase, up to 1040 days.

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

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.

General Publications

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)

March 6, 2017

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

May 28, 2020

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (ACTUAL)

February 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.121
  • 2016-002280-34 (EUDRACT_NUMBER)

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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