Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Finerenone (BAY94-8862); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 6016
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Corrientes, Argentina, 3400
    • Inst. de Cardiología de Corrientes Juana Francisca Cabral
  • Córdoba, Argentina, X5000AAX
    • Clinica Privada del Prado
  • Córdoba, Argentina, X5003DCE
    • Instituto Médico DAMIC- Fundación Rusculleda
  • Santa Fe, Argentina, S3000FWO
    • Centro de Investigaciones Clinicas del Litoral
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1179AAB
      • IMOBA Investigaciones Clinicas
    • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
      • Clínica Coronel Suarez
    • La Plata, Buenos Aires, Argentina, B1900
      • Hospital Italiano de La Plata | Clinical Research Department
    • Lanus, Buenos Aires, Argentina, B1824
      • Centro de Investigaciones Medicas Lanus | Research Department
    • Quilmes, Buenos Aires, Argentina
      • Sanatorio Modelo Quilmes
    • San Martín, Buenos Aires, Argentina, 1650
      • Corporación Médica de General San Martín
    • Zárate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clinicas Zarate
  • Ciudad Auton. De Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1056ABJ
      • Centro de Investigaciones Metabólicas
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1428ART
      • Instituto Cardiovascular de Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, 1426
      • Hospital Militar Central "CIR. MY. C. Argerich"
    • Caba, Ciudad Auton. De Buenos Aires, Argentina, C1018DES
      • Centro de Investigaciones Clínicas
    • Villa Luro, Ciudad Auton. De Buenos Aires, Argentina, C1440CFD
      • Centro de Especialidades Médicas
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Cardiovascular
    • Rosario, Santa Fe, Argentina, S2000DEJ
      • Instituto Medico de la Fundacion Estudios Clinicos
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Instituto de Cardiología
• Australia
  • Chermside, Australia, 4032
    • The Prince Charles Hospital
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • The Wesley Hospital
    • Herston, Queensland, Australia, 4006
      • Royal Brisbane and Women's Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Leabrook, South Australia, Australia, 5068
      • GenesisCare Leabrook
  • Victoria
    • Bundoora, Victoria, Australia, 3083
      • GenesisCare Ringwood
• Austria
  • Salzburg, Austria, 5020
    • Uniklinikum Salzburg - Landeskrankenhaus
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Wien, Austria, 1190
    • Imed19-privat
  • Wien, Austria, 1210
    • Klinik Floridsdorf - Krankenhaus Nord
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
      • Klinikum Klagenfurt am Wörthersee
  • Niederösterreich
    • St. Pölten, Niederösterreich, Austria, 3100
      • Universitätsklinikum St. Pölten
  • Oberösterreich
    • Braunau, Oberösterreich, Austria, 5280
      • Krankenhaus St. Josef Braunau
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6807
      • Landeskrankenhaus Feldkirch
• Brazil
  • Campinas, Brazil, 13060-803
    • PUC Campinas
  • Minas Gerais, Brazil, 38400-368
    • Eurolatino Pesquisas Médicas Ltda.
  • Bahia
    • Salvador, Bahia, Brazil, 40050-410
      • Santa Casa de Misericórdia da Bahia
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70100-000
      • Hospital do Coração do Brasil
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-020
      • Hospital das Clínicas de Goiânia
  • Parana
    • Curitiba, Parana, Brazil, 80045-170
      • QUANTA Diagnósticos e Terapia
    • Paraná, Parana, Brazil, 83430-000
      • Núcleo de Pesquisa Clínica do Hospital Angelina Caron
  • Rio Grande Do Sul
    • Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
      • Fundação Universidade de Caxias do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-000
      • Hospital Mae de Deus
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89020-430
      • MK Consultoria Médico Científica Ltda/Angiocor Blumenau
  • Sao Paulo
    • Belo Horizonte, Sao Paulo, Brazil, 30110-130
      • Hospital Felício Rocho
    • Campinas, Sao Paulo, Brazil, 13060-080
      • Inst. Pesq. Clínica de Campinas - Saraiva & Berlinger
    • Marília, Sao Paulo, Brazil, 17515-000
      • ICM - Instituto do Coração de Marília
    • Ribeirão Preto, Sao Paulo, Brazil, 14026-020
      • Centro Avançado de Pesquisa para Diagnóstico - CAPED
    • Tatui, Sao Paulo, Brazil, 18270-170
      • IMC - Instituto de Moléstias Cardiovasculares Tatuí
    • Votuporanga, Sao Paulo, Brazil
      • Santa Casa de Misericórdia de Votuporanga
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Clínica do Coração
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Ambulatory facility for specialized outpatient medical care
  • Haskovo, Bulgaria, 6300
    • MHAT Haskovo
  • Pazardjik, Bulgaria, 4400
    • MHAT Zdrave
  • Pernik, Bulgaria, 2300
    • ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult Pleven
  • Plovdiv, Bulgaria, 4000
    • Medical centre Hipokrat - N EOOD
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Medline Clinic
  • Plovdiv, Bulgaria, 4004
    • Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department
  • Shumen, Bulgaria, 9700
    • MHAT Shumen AD
  • Sliven, Bulgaria, 8800
    • MHAT Hadzhi Dimitar
  • Sofia, Bulgaria, 1233
    • NMTH Tzar Boris III
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Joanna-ISUL EAD Sofia
  • Sofia, Bulgaria, 1309
    • MHAT National Cardiology Hospital EAD
  • Sofia, Bulgaria, 1202
    • Second Medical Center Sofia EOOD
  • Sofia, Bulgaria, 1618
    • Multiprofile Hospital for Active Treatment Sveta Sofia
  • Sofia, Bulgaria, 1510
    • Medical Center Hera
  • Sofia, Bulgaria, 1233
    • Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
  • Stara Zagora, Bulgaria, 6000
    • MHAT Trakia
  • Veliko Tarnovo, Bulgaria, 5000
    • MHAT Dr Stefan Cherkezov
  • Yambol, Bulgaria, 8600
    • MHAT Sveti Pantaleymon - Yambol
• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials, Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates, Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Brampton Clinical Trials
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Center
    • Cambridge, Ontario, Canada, N1R 7R1
      • Vizel Cardiac Research
    • London, Ontario, Canada, N5R 6M6
      • London Health Sciences Centre
    • Mississauga, Ontario, Canada, L5K 2L3
      • KMH Cardiology Clinics Inc.
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiac Centre
    • Oakville, Ontario, Canada, L6K 3W7
      • Oakville Cardiovascular Research
    • Oshawa, Ontario, Canada, L1J 2K1
      • Office of Dr. James Cha, MD
    • Peterborough, Ontario, Canada, K9J 0B2
      • Kawartha Cardiology Clinical Trials
    • Scarborough, Ontario, Canada, M1B 5N1
      • Corcare
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M4P 1E4
      • Medicus MFC Inc.
    • Toronto, Ontario, Canada, M5F 1B2
      • Women's College Hospital
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Centre intégré de santé et de services sociaux de Laval, Hôp
    • Montreal, Quebec, Canada, H1T 3Y7
      • Clinique Sante Cardio MC
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal-CHUM
    • Montreal, Quebec, Canada, H4A 3J1
      • Montreal General Hospital
• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China, 102218
    • Beijing Tsinghua Changgung Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital, Capital Medical University
  • Shanghai, China
    • Shanghai Tongji Hospital of Tongji University
  • Shanghai, China, 200100
    • Shanghai East Hospital Affiated to Tongji University
  • Tianjin, China, 300000
    • Tianjin People's Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
    • Guangzhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzhou University of TCM
    • Guangzhou, Guangdong, China, 510630
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China, 510100
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital,Sun Yat-sen University
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Guizhou Provincial People's Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan Provincial People's Hospital
    • Sanya, Hainan, China, 572000
      • Hainan Third People's Hospital (Province Nongken Sanya Hopt)
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The First Hospital of Hebei Medical Univesity
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163311
      • Daqing Oilfield General Hospital
  • Henan
    • Xinxiang, Henan, China, 453000
      • Xinxiang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
    • Changsha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
  • Jiangsu
    • Huai'An, Jiangsu, China, 223300
      • Huai'an First People's Hospital, Nanjing Medical University
    • Lianyungang, Jiangsu, China, 222002
      • The First People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China, 210008
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210000
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 211103
      • Nanjing Jiangning Hospital
    • Suzhou, Jiangsu, China, 215006
      • 1st Affiliated hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
  • Liaoning
    • Panjin, Liaoning, China, 124010
      • Panjin Liaohe Oilfield Gem Flower Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
    • Yinchuan, Ningxia, China, 750001
      • The First People's Hospital of Yinchuan
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanxi
    • XI 'an, Shanxi, China, 710068
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710068
      • Shaanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University
    • Urumqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • 1st Affiliated Hospital of College Medicine, Zhejiang Univ.
• Colombia
  • Barranquilla, Colombia
    • Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)
  • Bogota, Colombia, 110131
    • Fundacion Cardioinfantil
  • Bogota, Colombia, 110621
    • Hospital Universitario Clínica San Rafael
  • Medellin, Colombia, 050010
    • Hospital San Vicente Fundación
  • Medellin, Colombia, 050034
    • Clinica Cardio VID
  • Santa Fe De Bogotá, Colombia
    • Hospital Universitario de San Ignacio
  • Antioquia
    • Medellin, Antioquia, Colombia, 050015
      • Hospital General de Medellin
    • Medellin, Antioquia, Colombia, 050021
      • Rodrigo Botero S.A.S
    • Medellín, Antioquia, Colombia
      • Hospital Alma Mater de Antioquia
    • Rionegro, Antioquia, Colombia, 054040
      • Sociedad Médica Rionegro SOMER S.A.
  • Atlántico
    • Baranquilla, Atlántico, Colombia, 080020
      • Clínica de la Costa SAS
    • Barranquilla, Atlántico, Colombia
      • Corazón IPS S.A.S.
    • Barranquilla, Atlántico, Colombia, 080020
      • IPS Centro Cientifico Asistencial S.A.S
  • Distrito Capital De Bogotá
    • Bogota, Distrito Capital De Bogotá, Colombia, 111061
      • Caja de Compensación Familiar CAFAM
  • Quindío
    • Armenia, Quindío, Colombia, 630004
      • Fundación Cardiomet CEQUIN Eje Cafetero
  • Santander
    • Bucaramanga, Santander, Colombia, 680002
      • Instituto del Corazón de Bucaramanga
  • Tolima
    • Ibague, Tolima, Colombia, 730006
      • Mediservis del Tolima IPS S.A.S
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760042
      • Clínica Imbanaco S.A.S
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Brno, Czechia, 612 00
    • Kardiologicka ambulance Brno s.r.o.
  • Brno, Czechia, 602 00
    • Kardiologie MUDr. Libor Nechvatal s.r.o.
  • Cesky Krumlov, Czechia, 381 01
    • Kardiologicka ambulance
  • Chlumec nad Cidlinou, Czechia, 503 51
    • Kardio Chlumec s.r.o.- Kardiologická ambulance
  • Dolni Brezany, Czechia, 252 41
    • Poliklinika Dolni Brezany
  • Hradec kralove, Czechia, 500 05
    • Fakultní nemocnice Hradec Králové
  • Kromeriz, Czechia, 767 01
    • LUNACOR, Centrum pro choroby srdce a cev
  • Kromeriz, Czechia, 767 55
    • Kromerizska nemocnice a.s.
  • Liberec, Czechia, 460 63
    • Krajska Nemocnice Liberec
  • Louny, Czechia, 440 01
    • KardioBusak s.r.o.
  • Pisek, Czechia, 39701
    • Kardiologicka a interni ambulance
  • Plzen, Czechia, 301 00
    • Fakultni nemocnice Plzen
  • Podebrady, Czechia, 290 01
    • Polabska zdravotni, s.r.o.
  • Praha 11 - Chodov, Czechia, 148 00
    • Affidea Praha s.r.o
  • Praha 2, Czechia, 12808
    • Vseobecna Fakultni nemocnice v Praze
  • Praha 4, Czechia, 140 21
    • Institut Klinicke a Experimentalni Mediciny
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Praha 6, Czechia, 169 02
    • Ustredni vojenska nemocnice Praha
  • Trebic, Czechia, 67401
    • Kardio s.r.o.
  • Trinec, Czechia, 73961
    • Nemocnice Podlesi
  • Zlin, Czechia, 760 01
    • Angiocor s.r.o.
  • Znojmo, Czechia, 669 02
    • Nemocnice Znojmo
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Sygehus Esbjerg | Kardiologisk Forskningsenhed
  • Hellerup, Denmark, 2900
    • Capital Region | Gentofte Hospital - Cardiology Research
  • Herlev, Denmark, 2730
    • Capital Region | Herlev Hospital - Department of Heart Disease
  • Herning, Denmark, 7400
    • Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart Research
  • Holbæk, Denmark, 4300
    • Holbæk Sygehus
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Randers, Denmark, 8930
    • Regionshospitalet Randers
  • Svendborg, Denmark, 5700
    • Odense University Hospital | Svendborg Hospital - Cardiovascular Research Unit
• Finland
  • Espoo, Finland, 02740
    • HUS Jorvin sairaala
  • Tampere, Finland, 33520
    • Tampereen yliopistollinen sairaala, keskussairaala
  • Turku, Finland, 20520
    • Turun Yliopistollinen keskussairaala
• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89077
      • Herzklinik Ulm GbR
  • Bayern
    • Würzburg, Bayern, Germany, 97078
      • Klinikum der Universität Würzburg
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover (MHH)
  • Nordrhein-Westfalen
    • Bielefeld, Nordrhein-Westfalen, Germany, 33604
      • Städt. Kliniken Bielefeld gGmbH
    • Remscheid, Nordrhein-Westfalen, Germany, 42859
      • Sana-Klinikum Remscheid GmbH
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • Forschungszentrum Ruhr - KliFoCenter GmbH
• Greece
  • Alexandroupoli, Greece, 68100
    • University General Hospital of Alexandroupolis
  • Ampelokipi - Athens, Greece, 11526
    • General Hosp of Athens "Korgialenio-Benakeio" RCH
  • Athens, Greece, 11527
    • G. GENNIMATAS General State Hospital of Athens
  • Athens, Greece, 115 27
    • Hippokration General Hospital of Athens
  • Athens, Greece, 11528
    • General Hospital of Athens "Alexandra"
  • Chaidari, Greece, 12462
    • University General Hospital Attikon
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Nea Ionia / Athens, Greece, 142 33
    • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
  • Patra, Greece, 26504
    • University General Hospital of Patra
  • Thessaloniki, Greece, 54642
    • Hippokration General Hospital of Thessaloniki
  • Attica
    • Kifisia / Athens, Attica, Greece, 14561
      • KAT General Hospital of Athens
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Kowloon, Hong Kong
    • Queen Elizabeth Hospital Hong Kong
  • Lai Chi Kok, Hong Kong
    • Princess Margaret Hospital
  • N.T
    • Shatin, N.T, Hong Kong
      • Prince of Wales Hospital
• Hungary
  • Balatonfured, Hungary, 8230
    • Cardiomobile Egeszsegugyi Szolgaltato Kft.
  • Budapest, Hungary, 1023
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1122
    • University of Semmelweis/ Semmelweis Egyetem
  • Budapest, Hungary, 1085
    • University of Semmelweis/ Semmelweis Egyetem
  • Budapest, Hungary
    • Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  • Budapest, Hungary, 1145
    • Budapesti Uzsoki Utcai Kórház
  • Budapest, Hungary, 1204
    • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Gyongyos, Hungary, 3200
    • Bugat Pal Korhaz
  • Gyongyos, Hungary, 3200
    • Pharma4Trial Kft.
  • Hodmezovasarhely, Hungary, 6800
    • Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Hospital
  • Nyiregyhaza, Hungary, 4400
    • Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
  • Pecs, Hungary, 7623
    • Coromed Smo Kft
  • Pecs, Hungary, 7635
    • Da Vinci Maganklinika
  • Szeged, Hungary, 6725
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Szekesfehervar, Hungary, 8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Szekszard, Hungary, 7100
    • Tolna Varmegyei Balassa Janos Korhaz
  • Szentes, Hungary, 6600
    • Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
• India
  • Delhi
    • New Delhi, Delhi, India, 110017
      • Max Super Speciality Hospital, Saket
    • New Delhi, Delhi, India, 110029
      • Safdarjung Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital
    • Pune, Maharashtra, India, 411011
      • KEM hospital
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600037
      • Madras Medical Mission Institute
• Israel
  • Ashdod, Israel, 7747629
    • Assuta Ashdod
  • Ashkelon, Israel, 7830604
    • Barzilai Ashkelon University Medical Center | Cardiology Department
  • Haifa, Israel, 3109601
    • Rambam Health Corporation
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Lower Galilee, Israel, 15208
    • Poriya Medical Center | Cardiology Department
  • Nahariya, Israel, 22100
    • Health Corporation of Galilee Medical Center
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Center
  • Zefat, Israel, 1311001
    • Health Corporation of the Ziv Medical Center (R.A.)
  • Zrifin, Israel, 7030000
    • Shamir Medical Center (Assaf Harofeh)
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • A.O.U. Mater Domini
  • Campania
    • Napoli, Campania, Italy, 80131
      • A.O.U. Policlinico Federico II Napoli
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40133
      • AUSL di Bologna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O.U. di Bologna Policlinico S.Orsola Malpighi
    • Ferrara, Emilia-Romagna, Italy, 44124
      • A.O.U. di Ferrara
    • Piacenza, Emilia-Romagna, Italy, 29121
      • AUSL di Piacenza
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • ASST Papa Giovanni XXIII
    • Brescia, Lombardia, Italy, 25123
      • Asst Spedali Civili Di Brescia
    • Brescia, Lombardia, Italy, 25085
      • ASST del Garda
    • Cremona, Lombardia, Italy, 26100
      • ASST di Cremona
    • Milano, Lombardia, Italy, 20089
      • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
    • Milano, Lombardia, Italy, 20138
      • IRCCS Centro Cardiologico Monzino S.p.A
    • Milano, Lombardia, Italy, 20138
      • IRCCS Istituti Clinici Scientifici Maugeri SpA SB
    • Monza Brianza, Lombardia, Italy, 20090
      • Asst Di Monza
    • Monza Brianza, Lombardia, Italy, 20871
      • ASST della Brianza
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo
    • Varese, Lombardia, Italy, 21049
      • ASST Sette Laghi
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • A.O.U. Maggiore della Carità
  • Toscana
    • Arezzo, Toscana, Italy, 52044
      • AUSL Toscana Sud-Est
    • Siena, Toscana, Italy, 53100
      • A.O.U. Senese
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • A.O. di Perugia
  • Veneto
    • Verona, Veneto, Italy, 37126
      • A.O.U.I. Verona
• Japan
  • Fukuoka, Japan, 814-8522
    • Fukuoka University Nishijin Hospital
  • Gifu, Japan, 500-8717
    • Gifu Prefectural General Medical Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Miyazaki, Japan, 880-2102
    • Miyazaki Medical Association Hospital
  • Niigata, Japan, 950-2087
    • Shinrakuen Hospital
  • Oita, Japan, 870-8511
    • Oita Prefectural Hospital
  • Okayama, Japan, 700-0804
    • The Sakakibara Heart Institute of Okayama
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Japan, 543-0035
    • Osaka Police Hospital
  • Osaka, Japan, 559-0012
    • Social Corporation Keigakukai Minamiosaka Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Wakayama, Japan, 649-6335
    • Seiyu Memorial Hospital
  • Aichi
    • Kasugai, Aichi, Japan, 486-8510
      • Kasugai Municipal Hospital
    • Toyota, Aichi, Japan, 471-8513
      • Toyota Memorial Hospital
  • Chiba
    • Funabashi, Chiba, Japan, 273-8588
      • Funabashi Municipal Medical Center
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 805-8508
      • Steel Memorial Yawata Hospital
    • Onga-gun, Fukuoka, Japan, 811-4342
      • Onga Nakama Medical Association Onga Hospital
  • Gifu
    • Ogaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Hiroshima
    • Shobara, Hiroshima, Japan, 727-0013
      • Shobara Red Cross Hospital
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8560
      • Hyogo Prefectural Harima-Himeji General Medical Center
    • Kobe, Hyogo, Japan, 654-0155
      • National Hospital Organization Kobe Medical Center
    • Takarazuka, Hyogo, Japan, 665-0873
      • Higashi Takarazuka Satoh Hospital
  • Ibaraki
    • Toride, Ibaraki, Japan, 302-0022
      • JA Toride Medical Center
  • Ishikawa
    • Hakusan, Ishikawa, Japan, 924-8588
      • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
    • Kanazawa, Ishikawa, Japan, 920-8650
      • National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
  • Iwate
    • Morioka, Iwate, Japan, 020-0066
      • Iwate Prefectural Central Hospital
  • Kagawa
    • Kanonji, Kagawa, Japan, 769-1695
      • Mitoyo General Hospital | Kagawa, Japan
    • Takamatsu, Kagawa, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
    • Sagamihara, Kanagawa, Japan, 252-5188
      • Sagamihara Kyodo Hospital
  • Nagano
    • Azumino, Nagano, Japan, 399-8292
      • Japan Red Cross Society Azumino Hospital
    • Ueda, Nagano, Japan, 386-8610
      • National Hospital Organization Shinshu Ueda Medical Center
  • Okinawa
    • Naha, Okinawa, Japan, 902-8511
      • R.I.A.C Naha City Hospital
  • Osaka
    • Kishiwada, Osaka, Japan, 596-0042
      • Kishiwada Tokushukai Hospital
    • Takatsuki, Osaka, Japan, 569-1096
      • Takatsuki Red Cross Hospital
  • Saitama
    • Ageo, Saitama, Japan, 362-8588
      • Ageo Central General Hospital
    • Kawaguchi, Saitama, Japan, 333-0842
      • Kawaguchi Cardiovascular and Respiratory Hospital
    • Sayama, Saitama, Japan, 350-1305
      • Saitama Sekishinkai Hospital
  • Shimane
    • Hamada, Shimane, Japan, 697-8511
      • National Hospital Organization Hamada Medical Center
  • Tokyo
    • Adachi-ku, Tokyo, Japan, 123-0845
      • Nishiarai Heart Central Clinic
    • Hachioji, Tokyo, Japan, 192-0918
      • Minamino Cardiovascular Hospital
    • Meguro-ku, Tokyo, Japan, 152-8902
      • National Hospital Organization Tokyo Medical Center
    • Ota-ku, Tokyo, Japan, 143-8541
      • Toho University Omori Medical Center
  • Tottori
    • Yonago, Tottori, Japan, 683-8605
      • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
  • Yamaguchi
    • Iwakuni, Yamaguchi, Japan, 740-8510
      • National Hospital Organization Iwakuni Clinical Center
    • Shimonoseki, Yamaguchi, Japan, 750-0061
      • JCHO Shimonoseki Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 602-715
    • Dong-A University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chung Nam National University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Chungcheongbugdo
    • Cheongju-si, Chungcheongbugdo, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gang''weondo
    • Wonju, Gang''weondo, Korea, Republic of, 26426
      • Yonsei University Wonju Christian Hospital
  • Gyeonggido
    • Anyang, Gyeonggido, Korea, Republic of, 431-070
      • Hallym University Sacred Heart Hospital
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
      • Bundang CHA Hospital
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
  • Jelgava, Latvia, LV-3001
    • Jelgava Outpatient Clinic
  • Liepaja, Latvia, LV-3414
    • Liepaja Regional Hospital
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital
  • Riga, Latvia, LV-1001
    • 1st Riga Clinical Hospital
  • Riga, Latvia, LV-1024
    • GK Neiroklinika
  • Ventspils, Latvia, LV-3601
    • Gita Rancane - cardiology private practice
• Lithuania
  • Alytus, Lithuania, LT-63200
    • UAB "Klinikiniai sprendimai" Alytus
  • Kaunas, Lithuania, LT-44320
    • LUHS Kauno Hospital (Laisves ave.)
  • Kaunas, Lithuania, LT-47144
    • LUHS Kauno Hospital (Josvainiu str.)
  • Kaunas, Lithuania, LT-49449
    • Saules family medicine center
  • Klaipeda, Lithuania, LT-92288
    • Klaipeda Seamen's Hospital
  • Siauliai, Lithuania, 76231
    • Siauliai Republican hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
• Malaysia
  • George Town,, Malaysia, 10050
    • Gleneagles Penang Medical Center
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50400
    • Institute Jantung Negara
  • Perak, Malaysia, 30450
    • Hospital Raja Permaisuri Bainun
  • Pulau Pinang, Malaysia, 10450
    • Hospital Pulau Pinang
  • Sarawak, Malaysia, 94300
    • Sarawak Heart Centre
  • Selangor, Malaysia, 43000
    • Hospital Serdang
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguascalientes
  • Durango, Mexico, 34080
    • Centro de Investigacion y Atencion Integral Durango S.C.
  • Coahuila
    • Torreón, Coahuila, Mexico, 27000
      • Centro de Investigación Médica Dr. Alberto Bazzoni SA de CV
  • Distrito Federal
    • Alcaldia Gustavo A. Madero, Distrito Federal, Mexico, 7300
      • Fundación de Atencion e Investigacion Medica Lindavista SC
    • Alcaldía Cuauhtemoc, Distrito Federal, Mexico, 06090
      • Hospital de Jesús
  • Guerrero
    • Acapulco, Guerrero, Mexico, 39910
      • Hospital General de Acapulco
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44657
      • Consultorio de Medicina Especializada del Sector Privado
  • Querétaro
    • Queretaro, Querétaro, Mexico, 76000
      • Centro de Estudios Clinicos de Queretaro S. C. (CECLIQ)
  • Veracruz
    • Xalapa, Veracruz, Mexico, 91193
      • Hospital Ángeles de Xalapa
• Netherlands
  • Almelo, Netherlands, 7609 PP
    • Ziekenhuis Groep Twente
  • Blaricum, Netherlands, 1261 AN
    • Tergooiziekenhuizen-Blaricum
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis
  • Doetinchem, Netherlands, 7009 BL
    • Slingeland Ziekenhuis
  • EDE, Netherlands, 6716 RP
    • Ziekenhuis Gelderse Vallei
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Groningen, Netherlands, 9700 RB
    • Universitair Medisch Centrum Groningen
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC
  • Meppel, Netherlands, 7943 KA
    • Diaconessenhuis Meppel
  • Sneek, Netherlands, 8601 ZR
    • Antonius Ziekenhuis Sneek
  • Veldhoven, Netherlands, 5504 DB
    • Maxima Medisch Centrum, locatie Veldhoven
• New Zealand
  • Auckland, New Zealand, 1023
    • University of Auckland
  • Christchurch, New Zealand, 8140
    • Christchurch Heart Institute
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Hawkes Bay, New Zealand, 4130
    • P3 Research Ltd Hawkes Bay
  • Lower Hutt, New Zealand, 5010
    • Hutt Hospital
  • Nelson, New Zealand, 7042
    • Nelson Hospital
  • Tauranga, New Zealand, 3110
    • P3 Research
• Poland
  • Bydgoszcz, Poland, 85-065
    • MICS Centrum Medyczne Bydgoszcz
  • Dzialki, Poland, 96-315
    • KLIMED Marek Klimkiewicz
  • Gdynia, Poland
    • Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej
  • Grodzisk Mazowiecki, Poland, 05 825
    • Samodzielny Publiczny Specjalistyczny Szpital Zachodni
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Krakow, Poland, 31-271
    • Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i Naczyn
  • Lublin, Poland, 20-857
    • NZOZ "Twoja Przychodnia" Sp. z o.o.
  • Lublin, Poland, 20-068
    • IMEDICA Centrum Medyczne
  • Olsztyn, Poland, 10-010
    • Zechowicz Medeusz-Plus Lekarska Spolka Partnerska
  • Oswiecim, Poland, 32-600
    • Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
  • Poznan, Poland, 61-848
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Pulawy, Poland, 24-100
    • Szpital Specjalistyczny SPZOZ
  • Sopot, Poland, 81-717
    • NZOZ Pro-Cordis Sopockie Centrum Badan Kardiologicznych
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Torun, Poland, 87-100
    • Gessek Jacek Prywatny Gabinet Lekarski
• Portugal
  • Amadora, Portugal, 2720-276
    • Hospital Prof. Dr. Fernando Fonseca
  • Aveiro, Portugal, 3810-501
    • BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios Clinicos
  • Coimbra, Portugal, 3004-561
    • Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Cardiology, Research Unit
  • Guarda, Portugal, 6300-659
    • ULSG - Unidade Local de Saude da Guarda
  • Leiria, Portugal, 2410-197
    • Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center
  • Lisboa, Portugal, 1449-005
    • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • Lisboa, Portugal, 1500-650
    • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
      • Hospital da Senhora da Oliveira | Clinical Research Department
  • Castelo Branco
    • Covilha, Castelo Branco, Portugal, 6200-251
      • Centro Hospitalar Universitario Cova de Beira | Clinical Research Department
  • Porto
    • Matosinhos, Porto, Portugal, 4464-513
      • ULSM - Hospital Pedro Hispano
  • Setúbal
    • Setubal, Setúbal, Portugal, 2900-722
      • Hospital da Luz - Setubal
• Romania
  • Baia Mare, Romania, 430031
    • Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
  • Braila, Romania, 810318
    • Emergency County Hospital, Braila
  • Brasov, Romania
    • S.C Thera Card S.R.L
  • Bucharest, Romania, 022322
    • Emergency Institute for Cardiovascular Diseases
  • Bucharest, Romania, 050098
    • Spitatul Universitar de Urgenta Bucuresti
  • Bucuresti, Romania, 022322
    • Emergency Institute for Cardiovascular Diseases
  • Bucuresti, Romania
    • Spitalul Clinic de Urgenta "Sf. Pantelimon"
  • Craiova Dolj, Romania, 200642
    • Emergency Clinical County Hospital Craiova
  • Galati, Romania, 800578
    • Sf. Ap. Andrei Emergency Clinical County Hospital Galati
  • Iasi, Romania, 700732
    • S.C. CARDIOMED S.R.L. Iasi
  • Pitesti, Romania
    • S.C. Sal Med SRL
  • Targu Mures, Romania, 540124
    • S.C. Cardio Med S.R.L.
  • Timisoara, Romania, 300310
    • Timisoara Institute of Cardiovascular Diseases
  • Timisoara, Romania, 300079
    • Municipal Clinical Emergency Hospital of Timisoara
  • Mures
    • Targu Mures, Mures, Romania
      • CMI. Dr. Podoleanu Cristian
  • Timis
    • Timisoara, Timis, Romania, 300040
      • Spitalul Clinic Municipal de Urgenta "Timisoara"
• Russian Federation
  • Aramil, Russian Federation, 624003
    • SBHI of Sverdlovsk Region Aramil City Hospital
  • Arkhangelsk, Russian Federation, 163001
    • First City Clinical Hospital n.a. E.E. Volosevich
  • Barnaul, Russian Federation, 656055
    • Altai Regional Cardiological Dispensary
  • Chita, Russian Federation, 672000
    • SBEI "Chita State Medical Academy"
  • Izhevsk, Russian Federation, 426063
    • Izhevsk City Clinical Hospital #9
  • Kazan, Russian Federation, 420008
    • Kazan Federal University
  • Kazan, Russian Federation, 420101
    • Clinical Diagnostic Center
  • Kemerovo, Russian Federation, 650002
    • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Kirov, Russian Federation, 610014
    • Center of Cardiology and Neurology
  • Moscow, Russian Federation, 119192
    • Moscow State University n.a. M.V. Lomonosov
  • Moscow, Russian Federation, 121309
    • City Clinical Hospital #51
  • Moscow, Russian Federation, 101990
    • Research center of therapy and prophylactic medicine
  • Moscow, Russian Federation, 117292
    • City clinical hospital n.a. V.V. Vinogradov
  • Moscow, Russian Federation, 129226
    • Russian Clinical and Research Center of Gerontology
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Clinical Hospital
  • Omsk, Russian Federation, 644018
    • Omsk Region "Clinical Health Unit No. 9"
  • Penza, Russian Federation, 440026
    • Penza Regional Clinical Hospital n.a. N.N. Burdenko
  • Perm, Russian Federation, 614097
    • Perm Regional Hospital for War Veterans
  • Rostov-on-Don, Russian Federation, 344068
    • Rostov-on-Don Emergency Clinical Hospital
  • Ryazan, Russian Federation, 390039
    • SBI of the Ryazan region "Regional clinical hospital"
  • Samara, Russian Federation, 443070
    • Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
  • Saratov, Russian Federation, 410054
    • Clinical Hospital #3 n.a. S.R. Mirotvortsev
  • St. Petersburg, Russian Federation, 199226
    • LLC Astarta
  • St. Petersburg, Russian Federation, 192242
    • Scien. Res. Inst. of Emergency Care n.a. I.I. Dzhanelidze
  • St. Petersburg, Russian Federation, 194017
    • St. Petersburg Clinical Hospital of RAS
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
  • Tomsk, Russian Federation, 634012
    • Scientific Research Institute of Cardiology
  • Yekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
  • Bardejov, Slovakia, 085 01
    • ALIAN s.r.o.
  • Bratislava, Slovakia, 813 69
    • Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
  • Bratislava, Slovakia, 811 08
    • Nemocnica svateho Michala, a.s.
  • Bratislava, Slovakia, 84107
    • Kardiosanus | Bratislava, Slovakia
  • Bratislava, Slovakia, 84103
    • Centrum interv. neuroradiologie a endovaskularnej liecby
  • Bratislava 37, Slovakia, 833 48
    • Narodny ustav srdcovych a cievnych chorob, a.s
  • Brezno, Slovakia, 977 01
    • Nemocnica s poliklinikou Brezno, n.o.
  • Dolny Kubin, Slovakia, 026 14
    • Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
  • Kosice, Slovakia, 040 01
    • JG-COR s.r.o.
  • Kosice, Slovakia, 040 01
    • Medical Group Kosice s.r.o. | Kosice, Slovakia
  • Levice, Slovakia, 934 01
    • KARDIO-ANGIO s.r.o.
  • Lucenec, Slovakia, 984 01
    • KardioMed s.r.o.
  • Moldava nad Bodvou, Slovakia, 045 01
    • MEDI M&M, s.r.o.
  • Nitra, Slovakia, 94901
    • Kardiocentrum Nitra | Cardiology Clinic - Outpatient Department
  • Nove Zamky, Slovakia, 940 01
    • KARDIOMED NZ s.r.o.
  • Presov, Slovakia, 080 01
    • MEDISPOL s.r.o.
  • Sahy, Slovakia, 936 01
    • COR, s.r.o
  • Zilina, Slovakia, 01001
    • Medivasa s.r.o.
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves|Cardiologia
  • Lleida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova de Lleida
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28023
    • Hospital Sanitas La Zarzuela | Cardiologia
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal | Medicina Interna
  • Salvador, Spain, 41253-190
    • Hospital San Rafael
  • Sevilla, Spain, 41014
    • Complejo Hospitalario Ntra. Sra. de Valme
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46940
    • Hospital de Manises
  • Valencia, Spain, 46026
    • La Fe University and Polytechnic Hospital | Cardiology Department
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
  • Alicante
    • San Bartolomé, Alicante, Spain, 03314
      • Hospital del Servei Valencià de Salud de la Vega Baja
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Central de Asturias
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
  • Cádiz
    • El Puerto de Santa María, Cádiz, Spain, 11500
      • Hospital Santa María del Puerto
    • Sanlucar de Barrameda, Cádiz, Spain, 11540
      • Jose Manuel Pascual Pascual S.A. | Hospital Virgen del Camino - Internal Medicine Department
    • Villamartin, Cádiz, Spain, 11650
      • Jose Manuel Pascual Pascual S.A. | Hospital Virgen de las Montanas - Internal Medicine Department
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
      • Hospital Dr. Negrín
  • Málaga
    • Malaga, Málaga, Spain, 29010
      • Hospital Universitario Virgen de la Victoria | Cardiology Department
  • Sevilla
    • Utrera, Sevilla, Spain, 41710
      • Hospital Alta Resolucion de Utrera | Cardiology Service Department
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Hsinchu, Taiwan, 300
    • Mackay Memorial Hospital - Hsinchu Branch
  • Taichung, Taiwan, 1650
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Tao-Yuan, Taiwan, 333
    • Chang Gung Memorial Hospital at Linkou
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 807377
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
• Turkey
  • Afyonkarahisar, Turkey, 03218
    • Afyonkarahisar Saglik Bilimleri Universitesi
  • Antalya, Turkey, 7100
    • Saglik Bilimleri Universitesi Antalya EA Hastanesi
  • Edirne, Turkey, 22030
    • Trakya Univ. Tip Fak.
  • Eskisehir, Turkey, 26480
    • Eskisehir Osmangazi Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey, 34304
    • Istanbul Universitesi Kardiyoloji Enstitusu
  • Istanbul, Turkey
    • Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
  • Izmir, Turkey, 35100
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Kayseri, Turkey, 38039
    • Erciyes Universitesi Tip Fakultesi
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Konya, Turkey, 42080
    • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
  • Kutahya, Turkey, 43040
    • Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve Arasti
  • Mersin, Turkey, 33079
    • Mersin Universitesi Tip Fakultesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Cherkasy Regional Cardiological Center
  • Dnipro, Ukraine, 49006
    • "Clinical Emergency Hospital" of Dnipro City Council
  • Kharkiv, Ukraine, 61039
    • National Institute of Therapy named after L.T.Maloyi
  • Kharkiv, Ukraine, 61166
    • Regional Dispensary of Radiation Protection of Population
  • Kharkiv, Ukraine, 61176
    • Miska Klinichna likarnya No 8
  • Kiev, Ukraine, 02 091
    • City Clinical Hospital # 1
  • Kiev, Ukraine, 03680
    • Institute of Cardiology AMS
  • Kyiv, Ukraine, 03037
    • Medbud-Clinic LLC
  • Kyiv, Ukraine, 03049
    • Railway Clinical Hospital #2
  • Kyiv, Ukraine, 04050
    • LLC Medical Centre CONSILIUM MEDICAL
  • Lviv, Ukraine, 79015
    • Lviv regional clinical medical & diagnostic cardiology cente
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
  • Uzhgorod, Ukraine, 880000
    • Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser
  • Vinnytsia, Ukraine, 21029
    • Vinnytsia City Clinical Hospital #1
  • Vinnytsya, Ukraine, 21018
    • Regional Clinical Hospital - Vinnytsya
  • Zaporizhzhja, Ukraine, 69005
    • Regional medical center of cardio-vascular disease
  • Zaporizhzhya, Ukraine, 69001
    • Zaporizhia Municipal Clinical Hospital No.10
  • Zaporizhzhya, Ukraine, 69005
    • Zaporizhzhya City Emergency Care Hospital
  • Zhytomyr, Ukraine, 10002
    • Communal Institution Central City Hospital 1 of Zhytomyr
• United Kingdom
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Glasgow, United Kingdom, G31 2ER
    • Glasgow Royal Infirmary | Glasgow Clinical Research Facility
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • Swindon, United Kingdom, SN3 6BB
    • Great Western Hospital
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth General Hospital
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Poole Hospital NHS Trust
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • North Hampshire Hospital
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Lister Hospital
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 8NR
      • Blackpool Victoria Hospital
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • University Hospitals Leicester
  • Northumberland
    • Ashington, Northumberland, United Kingdom, NE63 9JJ
      • Wansbeck General Hospital
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Russells Hall Hospital
  • West Sussex
    • Chichester, West Sussex, United Kingdom, PO19 6SE
      • St Richard's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology, PC
    • Fairhope, Alabama, United States, 36532
      • Eastern Shore Research Institute, LLC | Fairhope, AL
    • Mobile, Alabama, United States, 36608
      • Mobile Heart Specialists, PC
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Health Science Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Heart Clinic Arkansas
  • California
    • Beverly Hills, California, United States, 90211-2285
      • National Heart Institute
    • Cypress, California, United States, 90630
      • California Heart Specialists
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Heart & Vascular Institute
    • Santa Rosa, California, United States, 95405
      • NorthBay Clinical Research, LLC | Santa Rosa, CA
    • Torrance, California, United States, 90502
      • Harbor - UCLA Medical Center
    • Vista, California, United States, 92083
      • Blue Coast Research Center, LLC
    • West Hills, California, United States, 91307
      • Interventional Cardio Medical- DCT Department
    • West Hills, California, United States, 91307
      • Interventional Cardiology Medical Group | West Hills, CA
  • Colorado
    • Aurora, Colorado, United States, 80045
      • VA Eastern Colorado Health Care System
    • Colorado Springs, Colorado, United States, 80923
      • Colorado Springs Cardiology
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, PC
  • Florida
    • Bradenton, Florida, United States, 34209
      • Cardiovascular and Vein Center of Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research | Brandenton, FL
    • Daytona Beach, Florida, United States, 32117
      • Cardiology Associates Research Company
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Ctr
    • Miami, Florida, United States, 33130
      • LifeSpring Research Foundation, LLC
    • Naples, Florida, United States, 34102-8143
      • Southwest Florida Research | Naples, FL
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for Research, LLC - St Augustine
    • Wellington, Florida, United States, 33449
      • Cardiology Partners
  • Georgia
    • Columbus, Georgia, United States, 31904
      • IACT Health
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists, LLC
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Advocate Illinois Masonic Medical Center
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
    • Libertyville, Illinois, United States, 60048
      • Advocate Condell Medical Center
    • Naperville, Illinois, United States, 60540
      • Edward Hospital-Main Campus
    • North Chicago, Illinois, United States, 60064
      • Captain James A. Lovell Federal Health Care Center
    • Peoria, Illinois, United States, 61606
      • Methodist Medical Center of Illinois
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Midwest Cardiovascular Research and Education Foundation
    • Richmond, Indiana, United States, 47374
      • Reid Physician Associates | Cardiology Department
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Kansas Nephrology Research Institute, LLC
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Baptist Health Paducah
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Cardiovascular Associates Research, LLC
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond
    • Slidell, Louisiana, United States, 70458
      • Louisiana Heart Center Research - Slidell
    • Zachary, Louisiana, United States, 70791
      • Southern Clinical Research, LLC
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners-Maine Health Cardiology
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Outpatient Center
    • Baltimore, Maryland, United States, 21205
      • Cardiovascular Specialists of Central Maryland, PA
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Flint, Michigan, United States, 48504
      • Aa Mrc, Llc
    • Kalamazoo, Michigan, United States, 49007
      • Western Michigan University School of Medicine
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • M Health Fairview
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview Heart Clinic - Fulton
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
    • Jackson, Mississippi, United States, 39202
      • Baptist Heart -Cardiology - DCT Dept
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Harry S. Truman Memorial Veterans Hospital
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Mid America Heart Institute
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Montana
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • CHI Health Clinic Heart Institute - Grand Island
    • Lincoln, Nebraska, United States, 68526
      • CHI Health Nebraska Heart
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Advanced Heart Care, LLC | Bridgewater, NJ
    • Linden, New Jersey, United States, 07036
      • NJ Medcare/NJ Heart
    • Manalapan, New Jersey, United States, 07726
      • Garden State Heart Care
  • New York
    • Bronx, New York, United States, 10469
      • Cardiac Care & Vascular Medicine
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Cardiovascular Practice, PC
    • Riverhead, New York, United States, 11901
      • Division of Cardiovascular Research at Peconic Bay Med Ctr
    • Rosedale, New York, United States, 11422
      • Laurelton Heart Specialists
    • Saratoga Springs, New York, United States, 12866
      • Saratoga Clinical Research, LLC
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • Valley Stream, New York, United States, 11580
      • Northwell Health Phys. Partners Cardiology at Valley Stream
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Kernodle Clinic West, Private Diagnostic Clinic PLLC
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Wake Forest Baptist Health
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Kettering Health Network
    • Marion, Ohio, United States, 43302-6774
      • Rama Research LLC | Marion, OH
    • Youngstown, Ohio, United States, 44501
      • Mercy Health - St. Elizabeth Youngstown Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research, LLC
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Cardiology Associates-VIAA
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Kent Hospital
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Trident Cardiology Associates, PA
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
    • Mount Pleasant, South Carolina, United States, 29464
      • PMG Research of Charleston
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford USD Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation, Inc.
    • Jackson, Tennessee, United States, 38301
      • Apex Cardiology, LLC
    • Memphis, Tennessee, United States, 38104
      • Memphis VA Medical Center
    • Powell, Tennessee, United States, 37849
      • Cardiovascular Research of Knoxville
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Heart Institute
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates
    • Dallas, Texas, United States, 75231
      • Texas Health Physicians Group - Dallas
    • Fort Worth, Texas, United States, 76107
      • Texas Health Physicians Group - Fort Worth
    • Galveston, Texas, United States, 77555-0553
      • University of Texas Medical Branch at Galveston
    • Humble, Texas, United States, 77338
      • Houston Heart & Vascular Associates
    • Kerrville, Texas, United States, 78028
      • South Texas Cardiovascular Consultants, PLLC / Kerrville, TX
    • McKinney, Texas, United States, 75069-1780
      • North Dallas Research Associate | McKinney, TX
    • Plano, Texas, United States, 75024
      • ClinRx Research, LLC
    • San Antonio, Texas, United States, 78212-4740
      • Clinical Advancement Center, PLLC
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants, PLLC /San Antonio,TX
    • Tomball, Texas, United States, 77375
      • Northwest Houston Heart Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • IMG Cardiology- Fairfax
    • Falls Church, Virginia, United States, 22042
      • Virginia Heart
    • Leesburg, Virginia, United States, 20176
      • Virginia Heart
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center
    • Winchester, Virginia, United States, 22601
      • Selma Medical Associates
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Veterans Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant (male or female) must be aged 40 years and older.
• Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.
• On diuretic treatment for at least 30 days prior to randomization.
• Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
• Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm

• n-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm and patient does not have an ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation status is unknown or if patient has an ongoing diagnosis of paroxysmal atrial fibrillation) for participants obtained at the following time:

  • Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization OR
  • Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.
• Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.
• Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
• Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
• Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
• Coronary artery bypass graft surgery in the 90 days prior to randomization
• Percutaneous coronary intervention in the 30 days prior to randomization
• Stroke or transient ischemic cerebral attack within 90 days prior to randomization
• Probable alternative cause of participants' HF symptoms that in the opinion of the investigator primarily accounts for patient's dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) >50 kg/m2 at screening
• Systolic blood pressure(SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1_BAY94-8862; Adult patients receive BAY94-8862	Drug: Finerenone (BAY94-8862); For participants with an eGFR ≤60 mL/min/1.73 m^2: Starting dose is 10 mg OD and maximum dose 20 mg OD. For participants with an eGFR >60 mL/min/1.73 m^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets.
Placebo Comparator: Arm 2_Placebo; Adult patients receive placebo	Other: Placebo; Placebo tablets matching BAY94-8862 are administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cardiovascular deaths and heart failure events	Composite endpoint. Heart Failure events comprise first and recurrent events	Up to 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to total (first and recurrent) HF events		Up to 42 months
Improvement in NYHA class from Baseline to Month 12		Up to 12 month after start of treatment
Change in Total Symptom Score (TSS) from KCCQ.	Patient Reported Outcomes measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At baseline, Months 6, 9 and 12
Time to first occurrence of composite renal endpoint	Composite renal endpoint: sustained decrease in estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15ml/min/1.73m2 or initiation of dialysis or renal transplantation.	Up to 42 months
Time to death from any cause		Up to 42 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 5, 2024

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure with Preserved Ejection Fraction,; Mineralocorticoid receptor antagonist (MRA)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 20103; 2020-000306-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No