Studio con Omecamtiv Mecarbil (CK-1827452) per il trattamento dell'insufficienza cardiaca cronica con una frazione di eiezione gravemente ridotta (COMET-HF)
7 ottobre 2026 aggiornato da: Cytokinetics
Uno studio multicentrico, in doppio cieco, randomizzato, controllato con placebo per valutare l'efficacia e la sicurezza di Omecamtiv Mecarbil in pazienti con insufficienza cardiaca sintomatica con frazione di eiezione gravemente ridotta (COMET-HF)
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF).
Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed.
Estimated duration of participation: Up to 3 years.
Tipo di studio
Interventistico
Iscrizione (Stimato)
1800
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Cytokinetics MD
- Numero di telefono: (650) 624-2929
- Email: medicalaffairs@cytokinetics.com
Luoghi di studio
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
- Reclutamento
- Mazankowski Alberta Heart Institute / University of Alberta Hospital
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British Columbia
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Kelowna, British Columbia, Canada, V1Y1T2
- Reclutamento
- Kelowna General Hospital
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Surrey, British Columbia, Canada, V3V0C6
- Reclutamento
- SMH - Cardiology Clinical Trials Inc.
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Vancouver, British Columbia, Canada, V6Z1Y6
- Reclutamento
- St. Paul's Hospital
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Victoria, British Columbia, Canada, V8R1B2
- Reclutamento
- Victoria Heart Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
- Reclutamento
- St. Boniface Hospital
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Reclutamento
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A5A5
- Reclutamento
- London Health Sciences Centre
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Oakville, Ontario, Canada, L6M0L8
- Reclutamento
- Oakville Trafalgar Memorial Hospital - Halton Healthcare
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Toronto, Ontario, Canada, M4N1J7
- Reclutamento
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B1W8
- Reclutamento
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G2C4
- Reclutamento
- UHN-Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H1T1C8
- Reclutamento
- Montreal Heart Institute
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Sherbrooke, Quebec, Canada, J1L0H8
- Ritirato
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Canada, J6V 2H2
- Reclutamento
- CISSSL - Hopital Pierre-Le Gardeur
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Haikou, Cina, 570311
- Reclutamento
- Hainan General Hospital
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Hengyang, Cina, 421001
- Reclutamento
- The First Affiliated Hospital of University of South China
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100032
- Reclutamento
- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Cina, 400014
- Reclutamento
- Chongqing Emergency Medical Center
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Gansu
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Lanzhou, Gansu, Cina, 730030
- Reclutamento
- Lanzhou University Second
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Guangdong
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Guangzhou, Guangdong, Cina, 511400
- Reclutamento
- The Affiliated Panyu Central Hospital of Guangzhou Medical University
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Shenzhen, Guangdong, Cina, 518053
- Reclutamento
- The University of Hong Kong-Shenzhen Hospital
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Guangxi
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Nanning, Guangxi, Cina, 530020
- Reclutamento
- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Cina, 150001
- Reclutamento
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Luoyang, Henan, Cina, 471031
- Reclutamento
- The First Affiliated Hospital of Henan University of science and Technology
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Hunan
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Changsha, Hunan, Cina, 410011
- Reclutamento
- People's Hospital of Hunan Province
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Inner Mongolia
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Chifeng, Inner Mongolia, Cina, 024005
- Reclutamento
- Affiliated Hospital of Chifeng University
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Jiangsu
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Xuzhou, Jiangsu, Cina, 221002
- Reclutamento
- The Affiliated Hospital of Xuzhou Medical University
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Yangzhou, Jiangsu, Cina, 225001
- Reclutamento
- Northern Jiangsu People's Hospital
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Jilin
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Changchun, Jilin, Cina, 130033
- Reclutamento
- China-Japan Union Hospital of Jilin University
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Shandong
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Heze, Shandong, Cina, 274002
- Reclutamento
- Heze Municipal Hospital
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Jining, Shandong, Cina, 272029
- Reclutamento
- Affiliated Hospital of Jining Medical University
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Shanxi
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Taiyuan, Shanxi, Cina, 030024
- Reclutamento
- Shanxi Cardiovascular Hospital
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Yuncheng, Shanxi, Cina, 44000
- Reclutamento
- Yuncheng Central Hospital
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Taizhou
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Linhai, Taizhou, Cina, 317000
- Reclutamento
- Zhejiang Province Taizhou Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300457
- Reclutamento
- Teda International Cardiovascular Hospital
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Tianjin, Tianjin Municipality, Cina, 300020
- Reclutamento
- Tianjin Medical University General Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, Francia, 31059
- Reclutamento
- Centre Hospitalier Universitaire de Toulouse
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Hauts-de-France
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Valenciennes, Hauts-de-France, Francia, 59300
- Reclutamento
- Polyclinique Vauban
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Francia, 35033
- Reclutamento
- CHU de Rennes - Hôpital Pontchaillou
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Isère
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La Tronche, Isère, Francia, 38700
- Reclutamento
- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, Francia, 34295
- Reclutamento
- CHU de Montpellier- Hôpital Arnaud de Villeneuve
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Francia, 44277
- Reclutamento
- L'Hôpital Privé Du Confluent
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Rhône
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Bron, Rhône, Francia, 69677
- Reclutamento
- Hospices Civils de Lyon - Hôpital Louis Pradel
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Var
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Toulon, Var, Francia, 83100
- Reclutamento
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
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Île-de-France Region
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Paris, Île-de-France Region, Francia, 75010
- Reclutamento
- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, Francia, 75015
- Reclutamento
- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, Francia, 75018
- Reclutamento
- APHP - Hôpital Bichât
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Germania, 69120
- Reclutamento
- Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
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Bavaria
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München, Bavaria, Germania, 81377
- Reclutamento
- LMU Klinikum - Medizinische Klinik und Poliklinik I
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Würzburg, Bavaria, Germania, 97078
- Reclutamento
- Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, Germania, 20246
- Reclutamento
- UKE, Klinik für Kardiologie
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Hamburg, Free and Hanseatic City of Hamburg, Germania, 20246
- Reclutamento
- UKE, Klinik fur Kardiologie
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Germany
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Erfurt, Germany, Germania, 99089
- Reclutamento
- Helios Klinikum Erfurt GmbH
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Jena, Germany, Germania, 07747
- Reclutamento
- Universitaetsklinikum Jena
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Mainz, Germany, Germania, 55131
- Reclutamento
- Marienhaus Klinikum Mainz GmbH
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Hesse
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Bad Nauheim, Hesse, Germania, 61231
- Reclutamento
- Kerckhoff-Klinik GmbH
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Frankfurt am Main, Hesse, Germania, 60590
- Reclutamento
- Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
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Langen, Hesse, Germania, 63225
- Reclutamento
- Asklepios Klinik Langen-Seligenstadt GmbH
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Lower Saxony
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Göttingen, Lower Saxony, Germania, 37075
- Reclutamento
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Germania, 53127
- Reclutamento
- Universitätsklinikum Bonn
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Saarland
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Homburg, Saarland, Germania, 66424
- Reclutamento
- Uniklinikum Saarland
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Saxony
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Markkleeberg, Saxony, Germania, 04416
- Reclutamento
- Dr. med. Jens Taggeselle
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Attica
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Athens, Attica, Grecia, 11527
- Reclutamento
- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Grecia, 11527
- Reclutamento
- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Grecia, 14233
- Reclutamento
- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Grecia, 12462
- Reclutamento
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Grecia, 16673
- Reclutamento
- General Hospital ''Asklepieio Voulas''
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Euboea
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Chalcis, Euboea, Grecia, 34100
- Reclutamento
- General Hospital of Chalkida
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Evros
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Alexandroupoli, Evros, Grecia, 68100
- Reclutamento
- University General Hospital of Alexandroupolis
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Larissa
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Larissa, Larissa, Grecia, 41110
- Reclutamento
- University General Hospital of Larissa
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Thessaloniki
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Efkarpia, Thessaloniki, Grecia, 56403
- Reclutamento
- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Grecia, 54636
- Reclutamento
- AHEPA University General Hospital of Thessaloniki
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Cona, Italia, 44124
- Reclutamento
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italia, 00163
- Reclutamento
- IRCCS San Raffaele
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BS
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Brescia, BS, Italia, 25123
- Reclutamento
- ASST Spedali Civili di Brescia
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italia, 47923
- Reclutamento
- Ospedale Infermi
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Lombardy
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Arzignano, Lombardy, Italia, 36071
- Reclutamento
- Ospedale di Arzignano
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Bergamo, Lombardy, Italia, 24127
- Reclutamento
- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italia, 20138
- Reclutamento
- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italia, 20099
- Reclutamento
- IRCCS Multimedica
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MI
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Milan, MI, Italia, 20132
- Reclutamento
- IRCCS Ospedale San Raffaele
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Province of Perugia
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Perugia, Province of Perugia, Italia, 06129
- Reclutamento
- A.O. Perugia - Ospedale S.Maria della Misericordia
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Bialystok, Polonia, 15276
- Reclutamento
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Krakow, Polonia, 31202
- Reclutamento
- Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
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Lodz, Polonia, 90549
- Reclutamento
- SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
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Lodz, Polonia, 92213
- Reclutamento
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
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Miechów, Polonia, 32200
- Reclutamento
- Szpital Sw. Anny w Miechowie
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Opole, Polonia, 45401
- Reclutamento
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Polonia, 61848
- Reclutamento
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Ruda Śląska, Polonia, 41710
- Reclutamento
- Poradnia AKA-MED Centrum Sp. z o.o.
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Torun, Polonia, 87100
- Reclutamento
- Wojewodzki Szpital Zespolony im. L. Rydygiera
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Świdnik, Polonia, 21040
- Reclutamento
- Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 01249
- Reclutamento
- Balsammedica Sp. z o.o.
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Warsaw, Masovian Voivodeship, Polonia, 02-097
- Reclutamento
- Centralny Szpital Kliniczny UCK WUM
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Basingstoke, Regno Unito, RG249NA
- Reclutamento
- Basingstoke and North Hampshire Hospital
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Cottingham, Regno Unito, HU165JQ
- Reclutamento
- Castle Hill Hospital
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Dudley, Regno Unito, DY12HQ
- Reclutamento
- Russells Hall Hospital
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Dundonald, Regno Unito, BT161RH
- Reclutamento
- Ulster Hospital
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Glasgow, Regno Unito, G40SF
- Reclutamento
- Glasgow Royal Infirmary
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Swindon, Regno Unito, SN36BB
- Reclutamento
- Great Western Hospitals
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Greater London
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Harefield, Greater London, Regno Unito, UB96JH
- Reclutamento
- Harefield Hospital
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Hampshire
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Southampton, Hampshire, Regno Unito, SO166YD
- Reclutamento
- Southampton General Hospital
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Scotland
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Glasgow, Scotland, Regno Unito, G514TF
- Reclutamento
- Queen Elizabeth University Hospital
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A Coruña
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A Coruña, A Coruña, Spagna, 15006
- Reclutamento
- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Spagna, 15706
- Reclutamento
- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Spagna, 08035
- Reclutamento
- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona, Spagna, 08025
- Reclutamento
- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Barcelona, Spagna, 08907
- Reclutamento
- Hospital Universitari de Bellvitge
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Jaen
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Úbeda, Jaen, Spagna, 23400
- Reclutamento
- Hospital San Juan de la Cruz
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Lugo
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Lugo, Lugo, Spagna, 27003
- Reclutamento
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Spagna, 28041
- Reclutamento
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Spagna, 28046
- Reclutamento
- Hospital Universitario La Paz
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Majadahonda, Madrid, Spagna, 28222
- Reclutamento
- Hospital Universitario Puerta de Hierro
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Murcia
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El Palmar, Murcia, Spagna, 30120
- Reclutamento
- Hospital Universitario Virgen de La Arrixaca
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Pontevedra
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Vigo, Pontevedra, Spagna, 36312
- Reclutamento
- CHUVI - H.U. Alvaro Cunqueiro
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Salamanca
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Salamanca, Salamanca, Spagna, 37007
- Reclutamento
- Hospital Universitario de Salamanca
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Sevilla
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Seville, Sevilla, Spagna, 41013
- Reclutamento
- Hospital Universitario Virgen del Rocío
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Tarragona
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Tarragona, Tarragona, Spagna, 43005
- Reclutamento
- Hospital Universitari Joan XXIII de Tarragona
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Valencia
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Valencia, Valencia, Spagna, 46010
- Reclutamento
- Hospital Clínico Universitario de Valencia
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Valencia, Valencia, Spagna, 46026
- Reclutamento
- Hospital Universitari i Politecnic La Fe de Valencia
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-
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Alabama
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Alexander City, Alabama, Stati Uniti, 35010
- Reclutamento
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, Stati Uniti, 35233
- Reclutamento
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Stati Uniti, 85741
- Ritirato
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, Stati Uniti, 90211
- Reclutamento
- National Heart Institute
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La Jolla, California, Stati Uniti, 92037
- Reclutamento
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, Stati Uniti, 92350
- Reclutamento
- Nutrition Research Center (SPH)
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Los Angeles, California, Stati Uniti, 90033
- Reclutamento
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, Stati Uniti, 90095
- Reclutamento
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, Stati Uniti, 92868
- Reclutamento
- University of California, Irvine Medical Center
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Sacramento, California, Stati Uniti, 95817
- Reclutamento
- UC Davis Health
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Sacramento, California, Stati Uniti, 95816
- Reclutamento
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, Stati Uniti, 92123
- Reclutamento
- San Diego Cardiac Center
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San Francisco, California, Stati Uniti, 94109
- Reclutamento
- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, Stati Uniti, 95051
- Reclutamento
- Kaiser Permanente Santa Clara
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Stanford, California, Stati Uniti, 94303
- Reclutamento
- Stanford University Hospital / Stanford Health Care
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Torrance, California, Stati Uniti, 90502
- Reclutamento
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, Stati Uniti, 06606
- Reclutamento
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, Stati Uniti, 06102
- Reclutamento
- Hartford Hospital
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New Haven, Connecticut, Stati Uniti, 06519
- Reclutamento
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, Stati Uniti, 33756
- Reclutamento
- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, Stati Uniti, 33308
- Reclutamento
- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, Stati Uniti, 33351
- Reclutamento
- South Florida Research Solutions, LLC
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Jacksonville, Florida, Stati Uniti, 32209
- Reclutamento
- UF Health Jacksonville
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Miami Beach, Florida, Stati Uniti, 33140
- Reclutamento
- Broward Research Center
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Ocala, Florida, Stati Uniti, 34471
- Reclutamento
- Ocala Cardiovascular Research
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Orlando, Florida, Stati Uniti, 32803
- Reclutamento
- AdventHealth
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Tampa, Florida, Stati Uniti, 33606
- Reclutamento
- USF Health South Tampa Center for Advanced Healthcare
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Georgia
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Atlanta, Georgia, Stati Uniti, 30303
- Reclutamento
- Grady Health System
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Atlanta, Georgia, Stati Uniti, 30322
- Reclutamento
- Emory Clinic
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Atlanta, Georgia, Stati Uniti, 30309
- Reclutamento
- Piedmont Atlanta Hospital
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Fayetteville, Georgia, Stati Uniti, 30214
- Reclutamento
- Piedmont Fayette Hospital
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- Reclutamento
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, Stati Uniti, 60540
- Reclutamento
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Stati Uniti, 46321
- Reclutamento
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, Stati Uniti, 47630
- Reclutamento
- Deaconess Heart Group
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Richmond, Indiana, Stati Uniti, 47374
- Reclutamento
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- Reclutamento
- The University of Kansas Medical Center
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Overland Park, Kansas, Stati Uniti, 66211
- Reclutamento
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Reclutamento
- University Medical Center New Orleans
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Maine
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Bangor, Maine, Stati Uniti, 04401
- Reclutamento
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Reclutamento
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Reclutamento
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Stati Uniti, 48202
- Reclutamento
- Henry Ford Hospital
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Missouri
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Independence, Missouri, Stati Uniti, 64057
- Ritirato
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, Stati Uniti, 64111
- Reclutamento
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, Stati Uniti, 63110
- Reclutamento
- Washington University Center for Advanced Medicine
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St Louis, Missouri, Stati Uniti, 63136
- Ritirato
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198
- Reclutamento
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, Stati Uniti, 08807
- Reclutamento
- Advanced Heart Care, LLC
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Eatontown, New Jersey, Stati Uniti, 07724
- Reclutamento
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, Stati Uniti, 12205
- Reclutamento
- Capital Cardiology Associates
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Manhasset, New York, Stati Uniti, 11030
- Reclutamento
- Northwell Health North Shore University Hospital
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New York, New York, Stati Uniti, 10029
- Reclutamento
- Mount Sinai Hospital
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New York, New York, Stati Uniti, 10032
- Reclutamento
- Columbia University Medical Center / New York - Presbyterian
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The Bronx, New York, Stati Uniti, 10467
- Reclutamento
- Montefiore Medical Center (Moses Campus)
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North Carolina
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Cary, North Carolina, Stati Uniti, 27518
- Reclutamento
- WakeMed Heart & Vascular - Cary Cardiology
-
Chapel Hill, North Carolina, Stati Uniti, 27599-7064
- Reclutamento
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
-
Durham, North Carolina, Stati Uniti, 27710
- Reclutamento
- Duke University Hospital
-
Greensboro, North Carolina, Stati Uniti, 27401
- Reclutamento
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Reclutamento
- Wake Forest University Health Sciences
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45219
- Reclutamento
- The Lindner Research Center at the Christ Hospital
-
Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Stati Uniti, 44195
- Reclutamento
- Cleveland Clinic
-
Marion, Ohio, Stati Uniti, 43302
- Ritirato
- K&R Research LLC
-
Sandusky, Ohio, Stati Uniti, 44870
- Ritirato
- University of Hospitals North Ohio Heart
-
-
Oklahoma
-
Tulsa, Oklahoma, Stati Uniti, 74127
- Reclutamento
- Oklahoma State University Center for Health Sciences
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health and Science University
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Stati Uniti, 17011
- Reclutamento
- Capital Area Research, LLC
-
Hershey, Pennsylvania, Stati Uniti, 17033
- Reclutamento
- Penn State Health Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29425
- Reclutamento
- Medical University of South Carolina - Gazes Research Institute
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti, 57701
- Reclutamento
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
-
-
Tennessee
-
Germantown, Tennessee, Stati Uniti, 38138
- Reclutamento
- Stern Cardiovascular Foundation, Inc.
-
Knoxville, Tennessee, Stati Uniti, 37934
- Reclutamento
- Tennova Healthcare-Turkey Creek Medical Center
-
Nashville, Tennessee, Stati Uniti, 37232
- Reclutamento
- Vanderbilt University Medical Center
-
Tullahoma, Tennessee, Stati Uniti, 37388
- Reclutamento
- Tennessee Center for Clinical Trials
-
-
Texas
-
Dallas, Texas, Stati Uniti, 75246
- Reclutamento
- Baylor University Medical Center
-
Dallas, Texas, Stati Uniti, 75390
- Reclutamento
- The University of Texas Southwestern Medical Center
-
El Paso, Texas, Stati Uniti, 79902
- Ritirato
- Medresearch Inc
-
Galveston, Texas, Stati Uniti, 77555
- Reclutamento
- University of Texas Medical Branch - UTMB
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- CHI St. Luke's Health Baylor College of Medicine Medical Center
-
Plano, Texas, Stati Uniti, 75093
- Reclutamento
- Baylor Scott & White Medical Center- The Hearth Hospital
-
-
Utah
-
Murray, Utah, Stati Uniti, 84107
- Reclutamento
- Intermountain Medical Center
-
Salt Lake City, Utah, Stati Uniti, 84132
- Reclutamento
- University of Utah Health
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23507
- Ritirato
- Sentara Norfolk General Hospital
-
-
Washington
-
Spokane, Washington, Stati Uniti, 99204
- Reclutamento
- Providence Advanced Heart Disease and Transplant
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53226
- Reclutamento
- Medical College of Wisconsin / Froedtert Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
Adult patients who meet all the following criteria at screening may be included in the study:
-
Are between ≥ 18 years and ≤ 85 years at the signing of informed consent
-
Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening
-
Are receiving oral loop diuretics on a regular schedule
-
Patients without AFF on screening ECG:
- LVEF < 30% within 6 months of screening
- Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL)
-
Patients with AFF on screening ECG:
- LVEF < 25% within 6 months of screening
- Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL)
- Not currently taking digoxin
-
Meet one of the following criteria for a recent HF event:
- Are currently hospitalized with the primary reason of HF
- Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or
- Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.
-
Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
-
Systolic blood pressure ≤ 140 mmHg
Exclusion Criteria:
Any of the following criteria will exclude potential patients from the study:
- Have AFF on the screening ECG and are currently taking digoxin
- Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening
- Are admitted to a long-term care facility or hospice
- Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment
- Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening
- Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening
- Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)
- Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening
- Have previously had a solid organ transplant
- Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening
- Have received omecamtiv mecarbil in a previous clinical trial
- Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP
- Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Omecamtiv Mecarbil
Participants randomized to omecamtiv mecarbil will be dosed based on their omecamtiv mecarbil plasma concentration at 25, 37.5 or 50 mg twice daily until at least 850 participants experience a HF event or CV death, whichever comes first. |
Oral Tablet |
|
Comparatore placebo: Placebo
Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first. |
Oral Tablet |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care. |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to the first event of CV death or HF event
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first HF hospitalization
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to CV death
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to first event of stroke
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of stroke |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
|
Time to all-cause death
Lasso di tempo: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality |
From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Cytokinetics MD, Cytokinetics
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 dicembre 2024
Completamento primario (Stimato)
1 settembre 2027
Completamento dello studio (Stimato)
1 dicembre 2027
Date di iscrizione allo studio
Primo inviato
3 dicembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
13 dicembre 2024
Primo Inserito (Effettivo)
16 dicembre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 ottobre 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CY 1033
- 2024-519219-32-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .