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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04435626
Other study ID # 20103
Secondary ID 2020-000306-29
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 14, 2020
Est. completion date June 5, 2024

Study information

Verified date May 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6016
Est. completion date June 5, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Other:
Placebo
Placebo tablets matching BAY94-8862 are administered orally.

Locations

Country Name City State
Argentina Centro de Investigaciones Metabólicas Buenos Aires Ciudad Auton. De Buenos Aires
Argentina Hospital Militar Central "CIR. MY. C. Argerich" Buenos Aires Ciudad Auton. De Buenos Aires
Argentina Instituto Cardiovascular de Buenos Aires - Buenos Aires, Argentina Buenos Aires Ciudad Auton. De Buenos Aires
Argentina Centro de Investigaciones Clínicas Caba Ciudad Auton. De Buenos Aires
Argentina IMOBA Investigaciones Clinicas Caba Buenos Aires
Argentina Clínica Privada del Prado Córdoba
Argentina Instituto Médico DAMIC- Fundación Rusculleda Córdoba
Argentina Clínica Coronel Suarez Coronel Suarez Buenos Aires
Argentina Inst. de Cardiología de Corrientes Juana Francisca Cabral Corrientes
Argentina Hospital Italiano de La Plata | Clinical Research Department La Plata Buenos Aires
Argentina Centro de Investigaciones Medicas Lanus | Research Department Lanus Buenos Aires
Argentina Sanatorio Modelo Quilmes Quilmes Buenos Aires
Argentina Instituto Cardiovascular Rosario Santa Fe
Argentina Instituto Médico de la Fundación Estudios Clinicos Rosario Santa Fe
Argentina Corporación Médica de General San Martín San Martín Buenos Aires
Argentina Instituto de Cardiologia | Tucuman, AR San Miguel de Tucuman Tucuman
Argentina Centro de Investigaciones Clinicas del Litoral Santa Fe
Argentina Centro de Especialidades Médicas Villa Luro Ciudad Auton. De Buenos Aires
Argentina Instituto de Investigaciones Clínicas Zárate Zárate Buenos Aires
Australia The Wesley Hospital Auchenflower Queensland
Australia Flinders Medical Centre Bedford Park South Australia
Australia Advara HeartCare Ringwood Bundoora Victoria
Australia The Prince Charles Hospital Chermside
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Advara HeartCare Leabrook Leabrook South Australia
Australia John Hunter Hospital New Lambton Heights New South Wales
Austria Krankenhaus St. Josef Braunau Braunau Oberösterreich
Austria Landeskrankenhaus Feldkirch Feldkirch Vorarlberg
Austria Medizinische Universität Graz Graz Steiermark
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt Kärnten
Austria Uniklinikum Salzburg - Landeskrankenhaus Salzburg
Austria Universitätsklinikum St. Pölten St. Pölten Niederösterreich
Austria Imed19-privat Wien
Austria Klinik Floridsdorf - Krankenhaus Nord Wien
Austria Universitätsklinikum AKH Wien Wien
Brazil Centro de Pesquisa Clinica do Coração | Aracaju, Brasil Aracaju Sergipe
Brazil Hospital Felício Rocho Belo Horizonte Sao Paulo
Brazil MK Consultoria Médico Científica Ltda/Angiocor Blumenau Blumenau Santa Catarina
Brazil Hospital do Coração do Brasil Brasilia Distrito Federal
Brazil Campinas Clinical Research Institute (IPECC) | Campinas, Brazil Campinas Sao Paulo
Brazil Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas Campinas
Brazil Fundação Universidade de Caxias do Sul Caxias do Sul Rio Grande Do Sul
Brazil QUANTA Diagnósticos e Terapia Curitiba Parana
Brazil Hospital das Clínicas de Goiânia Goiânia Goiás
Brazil Instituto do Coração de Marilia | Marilia, Brasil Marília Sao Paulo
Brazil Eurolatino Pesquisas Medicas | Uberlandia, MG Minas Gerais
Brazil Sociedade Hospitalar Angelina Caron | Departamento de Ensino e Pesquisa Paraná Parana
Brazil Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center Porto Alegre Rio Grande Do Sul
Brazil Hospital Mae de Deus Porto Alegre Rio Grande Do Sul
Brazil Hospital Nossa Senhora da Conceição Porto Alegre Rio Grande Do Sul
Brazil Centro Avançado de Pesquisa para Diagnóstico - CAPED Ribeirão Preto Sao Paulo
Brazil Santa Casa de Misericórdia da Bahia Salvador Bahia
Brazil IMC - Instituto de Moléstias Cardiovasculares Tatui Tatui Sao Paulo
Brazil Santa Casa de Misericórdia de Votuporanga Votuporanga Sao Paulo
Bulgaria Ambulatory facility for specialized outpatient medical care Burgas
Bulgaria MHAT Haskovo Haskovo
Bulgaria MHAT Zdrave Pazardjik
Bulgaria ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD Pernik
Bulgaria Medical Center Medconsult Pleven Pleven
Bulgaria Medical centre Hipokrat - N EOOD Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment Medline | Cardiology Department Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department Plovdiv
Bulgaria Multiprofile Hospital for Active Treatment | Shumen - First Department of Internal Medicine Shumen
Bulgaria MHAT Hadzhi Dimitar Sliven
Bulgaria Medical Center Hera Sofia
Bulgaria MHAT National Cardiology Hospital EAD Sofia
Bulgaria Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department Sofia
Bulgaria Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department Sofia
Bulgaria NMTH Tzar Boris III Sofia
Bulgaria Second Medical Center Sofia EOOD Sofia
Bulgaria UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia
Bulgaria MHAT Trakia Stara Zagora
Bulgaria Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department Veliko Tarnovo
Bulgaria Multiprofile Hospital for Active Treatment Sveti Panteleymon Yambol | Cardiology Department Yambol
Canada Brampton Clinical Trials Brampton Ontario
Canada Cambridge Cardiac Care Center Cambridge Ontario
Canada Vizel Cardiac Research Cambridge Ontario
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada Centre intégré de santé et de services sociaux de Laval, Hôp Laval Quebec
Canada London Health Sciences Centre London Ontario
Canada KMH Cardiology Clinics Inc. Mississauga Ontario
Canada G.A. Research Associates, Ltd. Moncton New Brunswick
Canada Centre Hospitalier de l'Université de Montréal-CHUM Montreal Quebec
Canada Clinique Sante Cardio MC Montreal Quebec
Canada Montreal General Hospital Montreal Quebec
Canada Fraser Clinical Trials, Inc. New Westminster British Columbia
Canada North York Diagnostic and Cardiac Centre North York Ontario
Canada Oakville Cardiovascular Research Oakville Ontario
Canada Office of Dr. James Cha, MD Oshawa Ontario
Canada Kawartha Cardiology Clinical Trials Peterborough Ontario
Canada Corcare Scarborough Ontario
Canada Medicus MFC Inc. Toronto Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada Women's College Hospital Toronto Ontario
Canada St. Boniface Hospital Winnipeg Manitoba
China Beijing Anzhen Hospital, Capital Medical University Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing
China Beijing Tsinghua Changgung Hospital Beijing
China Jilin Province People's Hospital Changchun Jilin
China The First Hospital of Jilin University Changchun Jilin
China Changsha Central Hospital Changsha Hunan
China Hunan Provincial People's Hospital Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos Chengdu Sichuan
China West China Hospital Sichuan University Chengdu Sichuan
China Daqing Oilfield General Hospital Daqing Heilongjiang
China Fujian Provincial Hospital Fuzhou Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
China Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ. Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou University of TCM Guangzhou Guangdong
China The First Affiliated Hospital of Jinan University Guangzhou Guangdong
China The First Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong
China Guizhou Provincial People's Hospital Guiyang Guizhou
China Hainan Provincial People's Hospital Haikou Hainan
China 1st Affiliated Hospital of College Medicine, Zhejiang Univ. Hangzhou Zhejiang
China Huai'an First People's Hospital, Nanjing Medical University Huai'An Jiangsu
China Jinan Central Hospital Jinan Shandong
China Lanzhou University Second Hospital Lanzhou Gansu
China The First People's Hospital of Lianyungang Lianyungang Jiangsu
China Jiangsu Province Hospital Nanjing Jiangsu
China Nanjing Jiangning Hospital Nanjing Jiangsu
China NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical university Nanjing Jiangsu
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Panjin Liaohe Oilfield Gem Flower Hospital Panjin Liaoning
China Hainan Third People's Hospital (Province Nongken Sanya Hopt) Sanya Hainan
China Shanghai East Hospital Affiated to Tongji University Shanghai
China Shanghai Tongji Hospital of Tongji University Shanghai
China The First Hospital of Hebei Medical Univesity Shijiazhuang Hebei
China 1st Affiliated hospital of Soochow University Suzhou Jiangsu
China Tianjin People's Hospital Tianjin
China People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang
China The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Shanxi Provincial People's Hospital XI 'an Shanxi
China Shaanxi Provincial People's Hospital Xi'an Shanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Xinxiang Central Hospital Xinxiang Henan
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Yinchuan No.1 People's Hospital Yinchuan Ningxia
Colombia Fundación Cardiomet CEQUIN Eje Cafetero Armenia Quindío
Colombia Clínica de la Costa SAS Baranquilla Atlántico
Colombia Corazón IPS S.A.S. Barranquilla Atlántico
Colombia Fundacio del Caribe para la Investigacio Bio-Medica (BIOS) Barranquilla
Colombia IPS Centro Cientifico Asistencial S.A.S Barranquilla Atlántico
Colombia Caja de Compensación Familiar CAFAM Bogota Distrito Capital De Bogotá
Colombia Fundación Cardioinfantil Bogota
Colombia Hospital Universitario Clínica San Rafael Bogota
Colombia Instituto del Corazón de Bucaramanga Bucaramanga Santander
Colombia Clínica Imbanaco S.A.S Cali Valle Del Cauca
Colombia Mediservis del Tolima IPS S.A.S Ibague Tolima
Colombia Clinica Cardio VID Medellin
Colombia Hospital General de Medellin Medellin Antioquia
Colombia Hospital San Vicente Fundación Medellin
Colombia Rodrigo Botero S.A.S Medellin Antioquia
Colombia Hospital Alma Mater de Antioquia Medellín Antioquia
Colombia Sociedad Médica Rionegro SOMER S.A. Rionegro Antioquia
Colombia Hospital Universitario de San Ignacio Santa Fe De Bogotá
Czechia Fakultni nemocnice Brno Brno
Czechia Kardiologicka ambulance Brno s.r.o. Brno
Czechia Kardiologie MUDr. Libor Nechvatal s.r.o. Brno
Czechia Kardiologicka ambulance Cesky Krumlov
Czechia Kardio Chlumec s.r.o.- Kardiologicka ambulance Chlumec nad Cidlinou
Czechia Poliklinika Dolni Brezany Dolni Brezany
Czechia Fakultni Nemocnice Hradec Kralove Hradec kralove
Czechia Kromerizska nemocnice a.s. Kromeriz
Czechia LUNACOR, Centrum pro choroby srdce a cev Kromeriz
Czechia Krajska Nemocnice Liberec Liberec
Czechia KardioBusak s.r.o. Louny
Czechia Kardiologicka a interni ambulance Pisek
Czechia Fakultni nemocnice Plzen Plzen
Czechia Polabska zdravotni, s.r.o. Podebrady
Czechia Affidea Praha s.r.o Praha 11 - Chodov
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia Institut Klinicke a Experimentalni Mediciny Praha 4
Czechia Fakultni nemocnice v Motole Praha 5
Czechia Ustredni vojenska nemocnice Praha Praha 6
Czechia Kardio s.r.o. Trebic
Czechia Nemocnice Podlesi Trinec
Czechia Angiocor s.r.o. Zlin
Czechia Nemocnice Znojmo Znojmo
Denmark Aarhus Universitetshospital, Skejby Aarhus N
Denmark Sydvestjysk Sygehus Esbjerg | Kardiologisk Forskningsenhed Esbjerg
Denmark Capital Region | Gentofte Hospital - Cardiology Research Hellerup
Denmark Capital Region | Herlev Hospital - Department of Heart Disease Herlev
Denmark Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart Research Herning
Denmark Holbæk Sygehus Holbæk
Denmark Hvidovre Hospital Hvidovre
Denmark Regionshospitalet Randers Randers
Denmark Odense University Hospital | Svendborg Hospital - Cardiovascular Research Unit Svendborg
Finland HUS Jorvin sairaala Espoo
Finland Tampereen yliopistollinen sairaala, keskussairaala Tampere
Finland Turun yliopistollinen keskussairaala Turku
Germany Städt. Kliniken Bielefeld gGmbH Bielefeld Nordrhein-Westfalen
Germany Medizinische Hochschule Hannover (MHH) Hannover Niedersachsen
Germany Sana-Klinikum Remscheid GmbH Remscheid Nordrhein-Westfalen
Germany Herzklinik Ulm GbR Ulm Baden-Württemberg
Germany Forschungszentrum Ruhr - KliFoCenter GmbH Witten Nordrhein-Westfalen
Germany Klinikum der Universität Würzburg Würzburg Bayern
Greece University General Hospital of Alexandroupolis Alexandroupoli
Greece General Hosp of Athens "Korgialenio-Benakeio" RCH Ampelokipi - Athens
Greece G. GENNIMATAS General State Hospital of Athens Athens
Greece General Hospital of Athens "ALEXANDRA" Athens
Greece HIPPOKRATION General Hospital of Athens Athens
Greece University General Hospital ATTIKON Chaidari
Greece University General Hospital of Heraklion Heraklion
Greece KAT General Hospital of Athens Kifisia / Athens Attica
Greece University General Hospital of Larissa Larissa
Greece Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA Nea Ionia / Athens
Greece University General Hospital of Patra Patra
Greece Hippokration General Hospital of Thessaloniki Thessaloniki
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Queen Elizabeth Hospital Hong Kong Kowloon
Hong Kong Princess Margaret Hospital Lai Chi Kok
Hong Kong Prince of Wales Hospital Shatin N.T
Hungary Cardiomobile Egeszsegugyi Szolgaltato Kft. Balatonfured
Hungary Budai Irgalmasrendi Korhaz Budapest
Hungary Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet Budapest
Hungary Budapesti Uzsoki Utcai Korhaz Budapest
Hungary Eszak-Pesti Centrumkorhaz-Honvedkorhaz Budapest
Hungary University of Semmelweis/ Semmelweis Egyetem Budapest
Hungary University of Semmelweis/ Semmelweis Egyetem Budapest
Hungary Bugat Pal Korhaz Gyongyos
Hungary Pharma4Trial Kft. Gyongyos
Hungary Csongrad-Csanad Varmegyei Egeszsegugyi Ellato Kozpont Hodmezovasarhelyi Tagintezmeny Hodmezovasarhely
Hungary Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz Miskolc
Hungary Nagykanizsai Kanizsai Dorottya Korhaz Nagykanizsa
Hungary Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza
Hungary Coromed Smo Kft Pecs
Hungary Da Vinci Maganklinika Pecs
Hungary SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged
Hungary Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar
Hungary Tolna Varmegyei Balassa Janos Korhaz Szekszard
Hungary Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz Szentes
India Madras Medical Mission Institute Chennai Tamil Nadu
India Max Super Speciality Hospital, Saket New Delhi Delhi
India Safdarjung Hospital New Delhi Delhi
India Deenanath Mangeshkar Hospital Pune Maharashtra
India KEM hospital Pune Maharashtra
Israel Assuta Ashdod Ashdod
Israel Barzilai Ashkelon University Medical Center | Cardiology Department Ashkelon
Israel Bnai Zion Medical Center Haifa
Israel Lady Davis Carmel Medical Center Haifa
Israel Rambam Health Corporation Haifa
Israel Hadassah Hebrew University Hospital Ein Kerem Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Poriya Medical Center | Cardiology Department Lower Galilee
Israel Health Corporation of Galilee Medical Center Nahariya
Israel Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rehovot
Israel Tel-Aviv Sourasky Medical Center Tel Aviv
Israel Health Corporation of the Ziv Medical Center (R.A.) Zefat
Israel Shamir Medical Center (Assaf Harofeh) Zrifin
Italy AUSL Toscana Sud-Est Arezzo Toscana
Italy ASST Papa Giovanni XXIII Bergamo Lombardia
Italy A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna Emilia-Romagna
Italy AUSL di Bologna Bologna Emilia-Romagna
Italy ASST del Garda Brescia Lombardia
Italy ASST Spedali Civili di Brescia Brescia Lombardia
Italy A.O.U. Mater Domini Catanzaro Calabria
Italy ASST di Cremona Cremona Lombardia
Italy A.O.U. di Ferrara Ferrara Emilia-Romagna
Italy IRCCS Centro Cardiologico Monzino Milano Lombardia
Italy IRCCS Istituti Clinici Scientifici Maugeri SpA SB Milano Lombardia
Italy Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano Lombardia
Italy ASST della Brianza Monza Brianza Lombardia
Italy ASST di Monza Monza Brianza Lombardia
Italy A.O.U. Policlinico Federico II Napoli Napoli Campania
Italy A.O.U. Maggiore della Carità Novara Piemonte
Italy Fondazione IRCCS Policlinico San Matteo Pavia Lombardia
Italy A.O. di Perugia Perugia Umbria
Italy AUSL di Piacenza Piacenza Emilia-Romagna
Italy A.O.U. Senese Siena Toscana
Italy ASST Sette Laghi Varese Lombardia
Italy A.O.U.I. Verona Verona Veneto
Japan Nishiarai Heart Central Clinic Adachi-ku Tokyo
Japan Ageo Central General Hospital Ageo Saitama
Japan Japan Red Cross Society Azumino Hospital Azumino Nagano
Japan Fukuoka University Nishijin Hospital Fukuoka
Japan Funabashi Municipal Medical Center Funabashi Chiba
Japan Gifu Prefectural General Medical Center Gifu
Japan Minamino Cardiovascular Hospital Hachioji Tokyo
Japan Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office Hakusan Ishikawa
Japan National Hospital Organization Hamada Medical Center Hamada Shimane
Japan Hyogo Brain and Heart Center Himeji Hyogo
Japan National Hospital Organization Iwakuni Clinical Center Iwakuni Yamaguchi
Japan National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office Kanazawa Ishikawa
Japan Mitoyo General Hospital | Kagawa, Japan Kanonji Kagawa
Japan Kasugai Municipal Hospital Kasugai Aichi
Japan Kawaguchi Cardiovascular and Respiratory Hospital Kawaguchi Saitama
Japan Kishiwada Tokushukai Hospital Kishiwada Osaka
Japan Steel Memorial Yawata Hospital Kitakyushu Fukuoka
Japan National Hospital Organization Kobe Medical Center Kobe Hyogo
Japan Kumamoto University Hospital Kumamoto
Japan National Hospital Organization Kumamoto Medical Center Kumamoto
Japan National Hospital Organization Tokyo Medical Center Meguro-ku Tokyo
Japan Miyazaki Medical Association Hospital Miyazaki
Japan Iwate Prefectural Central Hospital Morioka Iwate
Japan R.I.A.C Naha City Hospital Naha Okinawa
Japan Shinrakuen Hospital Niigata
Japan Ogaki Municipal Hospital Ogaki Gifu
Japan Oita Prefectural Hospital Oita
Japan The Sakakibara Heart Institute of Okayama Okayama
Japan Onga Nakama Medical Association Onga Hospital Onga-gun Fukuoka
Japan Osaka General Medical Center Osaka
Japan Osaka Police Hospital | Clinical Research and Trial Center Osaka
Japan Social Corporation Keigakukai Minamiosaka Hospital Osaka
Japan Toho University Omori Medical Center Ota-ku Tokyo
Japan Kitasato University Hospital Sagamihara Kanagawa
Japan Sagamihara Kyodo Hospital Sagamihara Kanagawa
Japan Saitama Sekishinkai Hospital Sayama Saitama
Japan JCHO Shimonoseki Medical Center Shimonoseki Yamaguchi
Japan Shobara Red Cross Hospital Shobara Hiroshima
Japan Kagawa Prefectural Central Hospital Takamatsu Kagawa
Japan Higashi Takarazuka Satoh Hospital Takarazuka Hyogo
Japan Takatsuki Red Cross Hospital Takatsuki Osaka
Japan JA Toride Medical Center Toride Ibaraki
Japan Toyama University Hospital Toyama
Japan TOYOTA Memorial Hospital Toyota Aichi
Japan National Hospital Organization Shinshu Ueda Medical Center Ueda Nagano
Japan Seiyu Memorial Hospital Wakayama
Japan Japan Organization of Occupational Health and Safety Sanin Rosai Hospital Yonago Tottori
Korea, Republic of Hallym University Sacred Heart Hospital Anyang Gyeonggido
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Chungbuk National University Hospital Cheongju-si Chungcheongbugdo
Korea, Republic of Chung Nam National University Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Bundang Cha Hospital Seongnam-si Gyeonggido
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Yonsei University Wonju Christian Hospital Wonju Gang''weondo
Latvia Daugavpils Regional Hospital Daugavpils
Latvia Jelgava Outpatient Clinic Jelgava
Latvia Liepaja Regional Hospital Liepaja
Latvia 1st Riga Clinical Hospital Riga
Latvia GK Neiroklinika Riga
Latvia P. Stradins Clinical University Hospital Riga
Latvia Gita Rancane - cardiology private practice Ventspils
Lithuania UAB "Klinikiniai sprendimai" Alytus Alytus
Lithuania LUHS Kauno Hospital (Josvainiu str.) Kaunas
Lithuania LUHS Kauno Hospital (Laisves ave.) Kaunas
Lithuania Saules family medicine center Kaunas
Lithuania Klaipedos Jurininku Ligonine Klaipeda
Lithuania Siauliai Republican hospital Siauliai
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Malaysia Gleneagles Penang Medical Center George Town,
Malaysia Institute Jantung Negara Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Raja Permaisuri Bainun Perak
Malaysia Hospital Pulau Pinang Pulau Pinang
Malaysia Sarawak Heart Centre Sarawak
Malaysia Hospital Serdang Selangor
Mexico Hospital General de Acapulco Acapulco Guerrero
Mexico Hospital Cardiologica Aguascalientes Aguascalientes
Mexico Hospital de Jesús Alcaldía Cuauhtemoc Distrito Federal
Mexico Fundación de Atencion e Investigacion Medica Lindavista SC Alcaldia Gustavo A. Madero Distrito Federal
Mexico Centro de Investigacion y Atencion Integral Durango S.C. Durango
Mexico Consultorio de Medicina Especializada del Sector Privado Guadalajara Jalisco
Mexico Centro de Estudios Clinicos de Queretaro S. C. (CECLIQ) Queretaro Querétaro
Mexico Centro de Investigación Médica Dr. Alberto Bazzoni SA de CV Torreón Coahuila
Mexico Hospital Ángeles de Xalapa Xalapa Veracruz
Netherlands Ziekenhuis Groep Twente Almelo
Netherlands Tergooiziekenhuizen-Blaricum Blaricum
Netherlands Deventer Ziekenhuis Deventer
Netherlands Slingeland Ziekenhuis Doetinchem
Netherlands Ziekenhuis Gelderse Vallei Ede
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Ziekenhuis St. Jansdal Harderwijk
Netherlands Maastricht UMC Maastricht
Netherlands Isala Meppel Meppel
Netherlands Antonius Ziekenhuis Sneek Sneek
Netherlands Maxima Medisch Centrum, locatie Veldhoven Veldhoven
New Zealand University of Auckland Auckland
New Zealand Christchurch Heart Institute Christchurch
New Zealand Dunedin Hospital Dunedin
New Zealand P3 Research Ltd Hawkes Bay Hawkes Bay
New Zealand Hutt Hospital Lower Hutt
New Zealand Nelson Hospital Nelson
New Zealand P3 Research Tauranga
Poland KLIMED Marek Klimkiewicz Bialystok
Poland MICS Centrum Medyczne Bydgoszcz Bydgoszcz
Poland Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej Gdynia
Poland Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki
Poland CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice
Poland Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i Naczyn Krakow
Poland IMEDICA Centrum Medyczne Lublin
Poland NZOZ "Twoja Przychodnia" Sp. z o.o. Lublin
Poland Zechowicz Medeusz-Plus Lekarska Spolka Partnerska Olsztyn
Poland Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o. Oswiecim
Poland Uniwersytecki Szpital Kliniczny w Poznaniu Poznan
Poland Szpital Specjalistyczny SPZOZ Pulawy
Poland NZOZ Pro-Cordis Sopockie Centrum Badan Kardiologicznych Sopot
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland Gessek Jacek Prywatny Gabinet Lekarski Torun
Portugal Hospital Prof. Dr. Fernando Fonseca Amadora
Portugal BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios Clinicos Aveiro
Portugal Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Cardiology, Research Unit Coimbra
Portugal Centro Hospitalar Universitario Cova de Beira | Clinical Research Department Covilha Castelo Branco
Portugal ULSG - Unidade Local de Saude da Guarda Guarda
Portugal Hospital da Senhora da Oliveira | Clinical Research Department Guimaraes Braga
Portugal Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center Leiria
Portugal Centro Hospitalar de Lisboa Ocidental | Clin Res Dept Lisboa
Portugal Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica Lisboa
Portugal ULSM - Hospital Pedro Hispano Matosinhos Porto
Portugal Centro Hospitalar Universitario do Porto Porto
Portugal Hospital da Luz - Setubal Setubal Setúbal
Romania Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare Baia Mare
Romania Emergency County Hospital, Braila Braila
Romania S.C Thera Card S.R.L Brasov
Romania Emergency Institute for Cardiovascular Diseases Bucharest
Romania Spitatul Universitar de Urgenta Bucaresti Bucharest
Romania Emergency Institute for Cardiovascular Diseases Bucuresti
Romania Spitalul Clinic de Urgenta "Sf. Pantelimon" Bucuresti
Romania Emergency Clinical County Hospital Craiova Craiova Dolj
Romania Sf. Ap. Andrei Emergency Clinical County Hospital Galati Galati
Romania S.C. CARDIOMED S.R.L. Iasi Iasi
Romania S.C. Sal Med SRL Pitesti
Romania CMI. Dr. Podoleanu Cristian Targu Mures Mures
Romania S.C. Cardio Med S.R.L. Targu Mures
Romania Municipal Clinical Emergency Hospital of Timisoara Timisoara
Romania Spitalul Clinic Municipal de Urgenta "Timisoara" Timisoara Timis
Romania Timisoara Institute of Cardiovascular Diseases Timisoara
Russian Federation SBHI of Sverdlovsk Region Aramil City Hospital Aramil
Russian Federation First City Clinical Hospital n.a. E.E. Volosevich Arkhangelsk
Russian Federation Altai Regional Cardiological Dispensary Barnaul
Russian Federation SBEI "Chita State Medical Academy" Chita
Russian Federation Izhevsk City Clinical Hospital #9 Izhevsk
Russian Federation Clinical Diagnostic Center Kazan
Russian Federation Kazan Federal University Kazan
Russian Federation Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo
Russian Federation Center of cardiology and neurology Kirov
Russian Federation City Clinical Hospital #51 Moscow
Russian Federation City clinical hospital n.a. V.V. Vinogradov Moscow
Russian Federation Moscow State University n.a. M.V. Lomonosov Moscow
Russian Federation Research center of therapy and prophylactic medicine Moscow
Russian Federation Russian Clinical and Research Center of Gerontology Moscow
Russian Federation State Novosibirsk Regional Clinical Hospital Novosibirsk
Russian Federation Omsk Region "Clinical Health Unit No. 9" Omsk
Russian Federation Penza Regional Clinical Hospital n.a. N.N. Burdenko Penza
Russian Federation Perm Regional Hospital for War Veterans Perm
Russian Federation Rostov-on-Don Emergency Clinical Hospital Rostov-on-Don
Russian Federation SBI of the Ryazan region "Regional clinical hospital" Ryazan
Russian Federation Samara Regional Clinical Cardiology Dispensary n.a. Polyakov Samara
Russian Federation Clinical Hospital #3 n.a. S.R. Mirotvortsev Saratov
Russian Federation LLC Astarta St. Petersburg
Russian Federation Scien. Res. Inst. of Emergency Care n.a. I.I. Dzhanelidze St. Petersburg
Russian Federation St. Petersburg Clinical Hospital of RAS St. Petersburg
Russian Federation Scientific Research Institute of Cardiology Tomsk
Russian Federation Tomsk Regional Clinical Hospital Tomsk
Russian Federation Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg
Slovakia Stredoslovensky ustav srdcovych a cievnych chorob, a.s. Banska Bystrica
Slovakia ALIAN s.r.o. Bardejov
Slovakia Centrum interv. neuroradiologie a endovaskularnej liecby Bratislava
Slovakia Kardiosanus | Bratislava, Slovakia Bratislava
Slovakia Nemocnica svateho Michala, a.s. Bratislava
Slovakia Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto Bratislava
Slovakia Narodny ustav srdcovych a cievnych chorob, a.s Bratislava 37
Slovakia Nemocnica s poliklinikou Brezno, n.o. Brezno
Slovakia Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho Dolny Kubin
Slovakia JG-COR s.r.o. Kosice
Slovakia Medical Group Kosice s.r.o. | Kosice, Slovakia Kosice
Slovakia KARDIO-ANGIO s.r.o. Levice
Slovakia KardioMed s.r.o. Lucenec
Slovakia MEDI M&M, s.r.o. Moldava nad Bodvou
Slovakia Kardiocentrum Nitra | Cardiology Clinic - Outpatient Department Nitra
Slovakia KARDIOMED NZ s.r.o. Nove Zamky
Slovakia MEDISPOL s.r.o. Presov
Slovakia COR, s.r.o Sahy
Slovakia Medivasa s.r.o. Zilina
Spain Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Santa María del Puerto El Puerto de Santa María Cádiz
Spain Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial Ferrol A Coruña
Spain Hospital Universitario Virgen de las Nieves|Cardiologia Granada
Spain Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention L'Hospitalet de Llobregat Barcelona
Spain Hospital Dr. Negrín Las Palmas de Gran Canaria Las Palmas
Spain Hospital Universitario Arnau de Vilanova de Lleida Lleida
Spain Hospital Ramón y Cajal | Medicina Interna Madrid
Spain Hospital Sanitas La Zarzuela | Cardiologia Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Virgen de la Victoria | Cardiology Department Malaga Málaga
Spain Hospital Central de Asturias Oviedo Asturias
Spain Hospital San Rafael Salvador
Spain Hospital del Servei Valencià de Salud de la Vega Baja San Bartolomé Alicante
Spain Jose Manuel Pascual Pascual S.A. | Hospital Virgen del Camino - Internal Medicine Department Sanlucar de Barrameda Cádiz
Spain Complejo Hospitalario Ntra. Sra. de Valme Sevilla
Spain Hospital Alta Resolucion de Utrera | Cardiology Service Department Utrera Sevilla
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital de Manises Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain La Fe University and Polytechnic Hospital | Cardiology Department Valencia
Spain Jose Manuel Pascual Pascual S.A. | Hospital Virgen de las Montanas - Internal Medicine Department Villamartin Cádiz
Taiwan Changhua Christian Hospital Changhua
Taiwan Mackay Memorial Hospital - Hsinchu Branch Hsinchu
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Kaohsiung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Tao-Yuan
Turkey Afyonkarahisar Saglik Bilimleri Universitesi Afyonkarahisar
Turkey Saglik Bilimleri Universitesi Antalya EA Hastanesi Antalya
Turkey Trakya Univ. Tip Fak. Edirne
Turkey Eskisehir Osmangazi Universitesi Tip Fakultesi Eskisehir
Turkey Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H. Istanbul
Turkey Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul
Turkey Istanbul Universitesi Kardiyoloji Enstitusu Istanbul
Turkey Dokuz Eylul Universitesi Tip Fakultesi Izmir
Turkey Erciyes Universitesi Tip Fakultesi Kayseri
Turkey Kocaeli Universitesi Tip Fakultesi Kocaeli
Turkey Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi Konya
Turkey Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve Arasti Kutahya
Turkey Mersin Universitesi Tip Fakultesi Mersin
Ukraine Cherkasy Regional Cardiological Center Cherkasy
Ukraine "Clinical Emergency Hospital" of Dnipro City Council Dnipro
Ukraine Miska Klinichna likarnya No 8 Kharkiv
Ukraine National Institute of Therapy named after L.T.Maloyi Kharkiv
Ukraine Regional Dispensary of Radiation Protection of Population Kharkiv
Ukraine City Clinical Hospital # 1 Kiev
Ukraine Institute of Cardiology AMS Kiev
Ukraine LLC Medical Centre CONSILIUM MEDICAL Kyiv
Ukraine Medbud-Clinic LLC Kyiv
Ukraine Railway Clinical Hospital #2 Kyiv
Ukraine Lviv regional clinical medical & diagnostic cardiology cente Lviv
Ukraine Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi Poltava
Ukraine Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser Uzhgorod
Ukraine Vinnytsia City Clinical Hospital #1 Vinnytsia
Ukraine Regional Clinical Hospital - Vinnytsya Vinnytsya
Ukraine Regional medical center of cardio-vascular disease Zaporizhzhja
Ukraine Zaporizhia Municipal Clinical Hospital No.10 Zaporizhzhya
Ukraine Zaporizhzhya City Emergency Care Hospital Zaporizhzhya
Ukraine Communal Institution Central City Hospital 1 of Zhytomyr Zhytomyr
United Kingdom Wansbeck General Hospital Ashington Northumberland
United Kingdom North Hampshire Hospital Basingstoke Hampshire
United Kingdom Blackpool Victoria Hospital Blackpool Lancashire
United Kingdom Royal Bournemouth General Hospital Bournemouth Dorset
United Kingdom St Richard's Hospital Chichester West Sussex
United Kingdom Castle Hill Hospital Cottingham
United Kingdom Russells Hall Hospital Dudley West Midlands
United Kingdom Glasgow Royal Infirmary | Glasgow Clinical Research Facility Glasgow
United Kingdom Queen Elizabeth University Hospital Glasgow Glasgow City
United Kingdom University Hospitals Leicester Leicester Leicestershire
United Kingdom Manchester Royal Infirmary Manchester
United Kingdom Poole Hospital NHS Trust Poole Dorset
United Kingdom Lister Hospital Stevenage Hertfordshire
United Kingdom Great Western Hospital Swindon
United States VA Eastern Colorado Health Care System Aurora Colorado
United States Seton Heart Institute Austin Texas
United States Cardiovascular Specialists of Central Maryland, PA Baltimore Maryland
United States John Hopkins Outpatient Center Baltimore Maryland
United States Maryland Cardiovascular Specialists Baltimore Maryland
United States Suburban Hospital Bethesda Maryland
United States National Heart Institute Beverly Hills California
United States Cardiology, PC Birmingham Alabama
United States Cardiovascular & Vein Center of Florida | Bradenton, FL Bradenton Florida
United States Nova Clinical Research | Brandenton, FL Bradenton Florida
United States Advanced Heart Care, LLC | Bridgewater, NJ Bridgewater New Jersey
United States Cardiac Care & Vascular Medicine Bronx New York
United States Kernodle Clinic West, Private Diagnostic Clinic PLLC Burlington North Carolina
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States University of North Carolina Chapel Hill North Carolina
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States Colorado Springs Cardiology Colorado Springs Colorado
United States Harry S. Truman Memorial Veterans Hospital Columbia Missouri
United States IACT Health Columbus Georgia
United States Cardiovascular Associates Research, LLC Covington Louisiana
United States California Heart Specialists Cypress California
United States Southwest Family Medicine Associates Dallas Texas
United States Texas Health Physicians Group - Dallas Dallas Texas
United States Cardiology Associates Research Company Daytona Beach Florida
United States Henry Ford Health System Detroit Michigan
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Doylestown Cardiology Associates-VIAA Doylestown Pennsylvania
United States Midwest Cardiovascular Research and Education Foundation Elkhart Indiana
United States IMG Cardiology- Fairfax Fairfax Virginia
United States Eastern Shore Research Institute, LLC | Fairhope, AL Fairhope Alabama
United States Virginia Heart Falls Church Virginia
United States Aa Mrc, Llc Flint Michigan
United States Texas Health Physicians Group - Fort Worth Fort Worth Texas
United States Malcom Randall VA Medical Ctr Gainesville Florida
United States University of Texas Medical Branch at Galveston Galveston Texas
United States The Stern Cardiovascular Foundation, Inc. Germantown Tennessee
United States CHI Health Clinic Heart Institute - Grand Island Grand Island Nebraska
United States Heart Clinic of Hammond Hammond Louisiana
United States Houston Heart & Vascular Associates Humble Texas
United States Apex Cardiology, LLC Jackson Tennessee
United States Baptist Heart -Cardiology - DCT Dept Jackson Mississippi
United States University of Mississippi Medical Center Jackson Mississippi
United States Western Michigan University School of Medicine Kalamazoo Michigan
United States Logan Health Research Kalispell Montana
United States Clinical Research Consultants Kansas City Missouri
United States St. Luke's Mid America Heart Institute Kansas City Missouri
United States South Texas Cardiovascular Consultants, PLLC / Kerrville, TX Kerrville Texas
United States Kettering Health Network Kettering Ohio
United States Trident Cardiology Associates, PA Ladson South Carolina
United States Carolina Heart Specialists | Lancaster Lancaster South Carolina
United States Virginia Heart Leesburg Virginia
United States Advocate Condell Medical Center Libertyville Illinois
United States CHI Health Nebraska Heart Lincoln Nebraska
United States NJ Heart | Linden, NJ Linden New Jersey
United States Heart Clinic Arkansas Little Rock Arkansas
United States South Denver Cardiology Associates, PC Littleton Colorado
United States William S. Middleton Memorial Veterans Hospital Madison Wisconsin
United States Garden State Heart Care Manalapan New Jersey
United States M Health Fairview Maplewood Minnesota
United States Rama Research LLC | Marion, OH Marion Ohio
United States North Dallas Research Associate | McKinney, TX McKinney Texas
United States Lt. Col. Luke Weathers, Jr. VA Medical Center Memphis Tennessee
United States LifeSpring Research Foundation, LLC Miami Florida
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States M Health Fairview Heart Clinic - Fulton Minneapolis Minnesota
United States Mobile Heart Specialists, PC Mobile Alabama
United States PMG Research of Charleston Mount Pleasant South Carolina
United States Edward Hospital-Main Campus Naperville Illinois
United States Southwest Florida Research | Naples, FL Naples Florida
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Captain James A. Lovell Federal Health Care Center North Chicago Illinois
United States South Oklahoma Heart Research, LLC Oklahoma City Oklahoma
United States UC Irvine Medical Center Orange California
United States Baptist Health Paducah Paducah Kentucky
United States Methodist Medical Center of Illinois Peoria Illinois
United States ClinRx Research, LLC Plano Texas
United States Hudson Valley Cardiovascular Practice, PC Poughkeepsie New York
United States Cardiovascular Research of Knoxville Powell Tennessee
United States Monument Health Clinical Research Rapid City South Dakota
United States Reid Physician Associates | Cardiology Department Richmond Indiana
United States Division of Cardiovascular Research at Peconic Bay Med Ctr Riverhead New York
United States Laurelton Heart Specialists Rosedale New York
United States Sutter Heart & Vascular Institute Sacramento California
United States East Coast Institute for Research | St. Augustine, FL Saint Augustine Florida
United States St. Cloud Hospital Saint Cloud Minnesota
United States Salem VA Medical Center Salem Virginia
United States University of Utah Health Care Salt Lake City Utah
United States Clinical Advancement Center, PLLC San Antonio Texas
United States South Texas Cardiovascular Consultants, PLLC San Antonio Texas
United States NorthBay Clinical Research, LLC | Santa Rosa, CA Santa Rosa California
United States Saratoga Clinical Research, LLC Saratoga Springs New York
United States Maine Medical Partners-Maine Health Cardiology Scarborough Maine
United States Sanford USD Medical Center Sioux Falls South Dakota
United States Louisiana Heart Center Research - Slidell Slidell Louisiana
United States Mercy Hospital Springfield Springfield Missouri
United States Stony Brook University Medical Center Stony Brook New York
United States Northwest Houston Heart Center Tomball Texas
United States Harbor - UCLA Medical Center Torrance California
United States Atlanta Heart Specialists, LLC Tucker Georgia
United States University of Arizona Health Science Center Tucson Arizona
United States Northwell Health Phys. Partners Cardiology at Valley Stream Valley Stream New York
United States Blue Coast Research Center, LLC Vista California
United States Kent Hospital Warwick Rhode Island
United States Aspirus Research Institute Wausau Wisconsin
United States Cardiology Partners Wellington Florida
United States Interventional Cardio Medical- DCT Department West Hills California
United States Interventional Cardiology Medical Group | West Hills, CA West Hills California
United States Kansas Nephrology Research Institute, LLC Wichita Kansas
United States Selma Medical Associates Winchester Virginia
United States Wake Forest Baptist Health Winston-Salem North Carolina
United States Mercy Health - St. Elizabeth Youngstown Hospital Youngstown Ohio
United States Southern Clinical Research, LLC Zachary Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of cardiovascular deaths and heart failure events Composite endpoint. Heart Failure events comprise first and recurrent events Up to 42 months
Secondary Time to total (first and recurrent) HF events Up to 42 months
Secondary Improvement in NYHA class from Baseline to Month 12 Up to 12 month after start of treatment
Secondary 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
Secondary 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
Secondary Time to death from any cause Up to 42 months
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