Étude avec Omecamtiv Mecarbil (CK-1827452) pour traiter l'insuffisance cardiaque chronique avec une fraction d'éjection sévèrement réduite (COMET-HF)
7 octobre 2026 mis à jour par: Cytokinetics
Un essai multicentrique, en double aveugle, randomisé et contrôlé par placebo pour évaluer l'efficacité et l'innocuité d'Omecamtiv Mecarbil chez les patients présentant une insuffisance cardiaque symptomatique avec une fraction d'éjection sévèrement réduite (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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
1800
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Cytokinetics MD
- Numéro de téléphone: (650) 624-2929
- E-mail: medicalaffairs@cytokinetics.com
Lieux d'étude
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Allemagne, 69120
- Recrutement
- Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
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Bavaria
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München, Bavaria, Allemagne, 81377
- Recrutement
- LMU Klinikum - Medizinische Klinik und Poliklinik I
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Würzburg, Bavaria, Allemagne, 97078
- Recrutement
- 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, Allemagne, 20246
- Recrutement
- UKE, Klinik für Kardiologie
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Hamburg, Free and Hanseatic City of Hamburg, Allemagne, 20246
- Recrutement
- UKE, Klinik fur Kardiologie
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Germany
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Erfurt, Germany, Allemagne, 99089
- Recrutement
- Helios Klinikum Erfurt GmbH
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Jena, Germany, Allemagne, 07747
- Recrutement
- Universitaetsklinikum Jena
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Mainz, Germany, Allemagne, 55131
- Recrutement
- Marienhaus Klinikum Mainz GmbH
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Hesse
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Bad Nauheim, Hesse, Allemagne, 61231
- Recrutement
- Kerckhoff-Klinik GmbH
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Frankfurt am Main, Hesse, Allemagne, 60590
- Recrutement
- Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
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Langen, Hesse, Allemagne, 63225
- Recrutement
- Asklepios Klinik Langen-Seligenstadt GmbH
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Lower Saxony
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Göttingen, Lower Saxony, Allemagne, 37075
- Recrutement
- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Allemagne, 53127
- Recrutement
- Universitätsklinikum Bonn
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Saarland
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Homburg, Saarland, Allemagne, 66424
- Recrutement
- Uniklinikum Saarland
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Saxony
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Markkleeberg, Saxony, Allemagne, 04416
- Recrutement
- Dr. med. Jens Taggeselle
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
- Recrutement
- Mazankowski Alberta Heart Institute / University of Alberta Hospital
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British Columbia
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Kelowna, British Columbia, Canada, V1Y1T2
- Recrutement
- Kelowna General Hospital
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Surrey, British Columbia, Canada, V3V0C6
- Recrutement
- SMH - Cardiology Clinical Trials Inc.
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Vancouver, British Columbia, Canada, V6Z1Y6
- Recrutement
- St. Paul's Hospital
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Victoria, British Columbia, Canada, V8R1B2
- Recrutement
- Victoria Heart Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
- Recrutement
- St. Boniface Hospital
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Recrutement
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A5A5
- Recrutement
- London Health Sciences Centre
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Oakville, Ontario, Canada, L6M0L8
- Recrutement
- Oakville Trafalgar Memorial Hospital - Halton Healthcare
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Toronto, Ontario, Canada, M4N1J7
- Recrutement
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B1W8
- Recrutement
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G2C4
- Recrutement
- UHN-Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H1T1C8
- Recrutement
- Montreal Heart Institute
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Sherbrooke, Quebec, Canada, J1L0H8
- Retiré
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Canada, J6V 2H2
- Recrutement
- CISSSL - Hopital Pierre-Le Gardeur
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Haikou, Chine, 570311
- Recrutement
- Hainan General Hospital
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Hengyang, Chine, 421001
- Recrutement
- The First Affiliated Hospital of University of South China
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100032
- Recrutement
- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine, 400014
- Recrutement
- Chongqing Emergency Medical Center
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Gansu
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Lanzhou, Gansu, Chine, 730030
- Recrutement
- Lanzhou University Second
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Guangdong
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Guangzhou, Guangdong, Chine, 511400
- Recrutement
- The Affiliated Panyu Central Hospital of Guangzhou Medical University
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Shenzhen, Guangdong, Chine, 518053
- Recrutement
- The University of Hong Kong-Shenzhen Hospital
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Guangxi
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Nanning, Guangxi, Chine, 530020
- Recrutement
- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Chine, 150001
- Recrutement
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Luoyang, Henan, Chine, 471031
- Recrutement
- The First Affiliated Hospital of Henan University of science and Technology
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Hunan
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Changsha, Hunan, Chine, 410011
- Recrutement
- People's Hospital of Hunan Province
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Inner Mongolia
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Chifeng, Inner Mongolia, Chine, 024005
- Recrutement
- Affiliated Hospital of Chifeng University
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Jiangsu
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Xuzhou, Jiangsu, Chine, 221002
- Recrutement
- The Affiliated Hospital of Xuzhou Medical University
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Yangzhou, Jiangsu, Chine, 225001
- Recrutement
- Northern Jiangsu People's Hospital
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Jilin
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Changchun, Jilin, Chine, 130033
- Recrutement
- China-Japan Union Hospital of Jilin University
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Shandong
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Heze, Shandong, Chine, 274002
- Recrutement
- Heze Municipal Hospital
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Jining, Shandong, Chine, 272029
- Recrutement
- Affiliated Hospital of Jining Medical University
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Shanxi
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Taiyuan, Shanxi, Chine, 030024
- Recrutement
- Shanxi Cardiovascular Hospital
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Yuncheng, Shanxi, Chine, 44000
- Recrutement
- Yuncheng Central Hospital
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Taizhou
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Linhai, Taizhou, Chine, 317000
- Recrutement
- Zhejiang Province Taizhou Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300457
- Recrutement
- Teda International Cardiovascular Hospital
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Tianjin, Tianjin Municipality, Chine, 300020
- Recrutement
- Tianjin Medical University General Hospital
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A Coruña
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A Coruña, A Coruña, Espagne, 15006
- Recrutement
- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Espagne, 15706
- Recrutement
- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Espagne, 08035
- Recrutement
- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona, Espagne, 08025
- Recrutement
- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Barcelona, Espagne, 08907
- Recrutement
- Hospital Universitari de Bellvitge
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Jaen
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Úbeda, Jaen, Espagne, 23400
- Recrutement
- Hospital San Juan de la Cruz
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Lugo
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Lugo, Lugo, Espagne, 27003
- Recrutement
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Espagne, 28041
- Recrutement
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Espagne, 28046
- Recrutement
- Hospital Universitario La Paz
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Majadahonda, Madrid, Espagne, 28222
- Recrutement
- Hospital Universitario Puerta de Hierro
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Murcia
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El Palmar, Murcia, Espagne, 30120
- Recrutement
- Hospital Universitario Virgen de La Arrixaca
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Pontevedra
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Vigo, Pontevedra, Espagne, 36312
- Recrutement
- CHUVI - H.U. Alvaro Cunqueiro
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Salamanca
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Salamanca, Salamanca, Espagne, 37007
- Recrutement
- Hospital Universitario de Salamanca
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Sevilla
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Seville, Sevilla, Espagne, 41013
- Recrutement
- Hospital Universitario Virgen del Rocío
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Tarragona
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Tarragona, Tarragona, Espagne, 43005
- Recrutement
- Hospital Universitari Joan XXIII de Tarragona
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Valencia
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Valencia, Valencia, Espagne, 46010
- Recrutement
- Hospital Clínico Universitario de Valencia
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Valencia, Valencia, Espagne, 46026
- Recrutement
- Hospital Universitari i Politecnic La Fe de Valencia
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31059
- Recrutement
- Centre Hospitalier Universitaire de Toulouse
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Hauts-de-France
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Valenciennes, Hauts-de-France, France, 59300
- Recrutement
- Polyclinique Vauban
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35033
- Recrutement
- CHU de Rennes - Hôpital Pontchaillou
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Isère
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La Tronche, Isère, France, 38700
- Recrutement
- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, France, 34295
- Recrutement
- 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, France, 44277
- Recrutement
- L'Hôpital Privé Du Confluent
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Rhône
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Bron, Rhône, France, 69677
- Recrutement
- Hospices Civils de Lyon - Hôpital Louis Pradel
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Var
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Toulon, Var, France, 83100
- Recrutement
- 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, France, 75010
- Recrutement
- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, France, 75015
- Recrutement
- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, France, 75018
- Recrutement
- APHP - Hôpital Bichât
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Attica
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Athens, Attica, Grèce, 11527
- Recrutement
- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Grèce, 11527
- Recrutement
- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Grèce, 14233
- Recrutement
- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Grèce, 12462
- Recrutement
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Grèce, 16673
- Recrutement
- General Hospital ''Asklepieio Voulas''
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Euboea
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Chalcis, Euboea, Grèce, 34100
- Recrutement
- General Hospital of Chalkida
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Evros
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Alexandroupoli, Evros, Grèce, 68100
- Recrutement
- University General Hospital of Alexandroupolis
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Larissa
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Larissa, Larissa, Grèce, 41110
- Recrutement
- University General Hospital of Larissa
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Thessaloniki
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Efkarpia, Thessaloniki, Grèce, 56403
- Recrutement
- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Grèce, 54636
- Recrutement
- AHEPA University General Hospital of Thessaloniki
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Cona, Italie, 44124
- Recrutement
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italie, 00163
- Recrutement
- IRCCS San Raffaele
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BS
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Brescia, BS, Italie, 25123
- Recrutement
- ASST Spedali Civili di Brescia
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italie, 47923
- Recrutement
- Ospedale Infermi
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Lombardy
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Arzignano, Lombardy, Italie, 36071
- Recrutement
- Ospedale di Arzignano
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Bergamo, Lombardy, Italie, 24127
- Recrutement
- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italie, 20138
- Recrutement
- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italie, 20099
- Recrutement
- IRCCS Multimedica
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MI
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Milan, MI, Italie, 20132
- Recrutement
- IRCCS Ospedale San Raffaele
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Province of Perugia
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Perugia, Province of Perugia, Italie, 06129
- Recrutement
- A.O. Perugia - Ospedale S.Maria della Misericordia
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Bialystok, Pologne, 15276
- Recrutement
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Krakow, Pologne, 31202
- Recrutement
- Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
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Lodz, Pologne, 90549
- Recrutement
- SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
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Lodz, Pologne, 92213
- Recrutement
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
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Miechów, Pologne, 32200
- Recrutement
- Szpital Sw. Anny w Miechowie
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Opole, Pologne, 45401
- Recrutement
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Pologne, 61848
- Recrutement
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Ruda Śląska, Pologne, 41710
- Recrutement
- Poradnia AKA-MED Centrum Sp. z o.o.
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Torun, Pologne, 87100
- Recrutement
- Wojewodzki Szpital Zespolony im. L. Rydygiera
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Świdnik, Pologne, 21040
- Recrutement
- Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Pologne, 01249
- Recrutement
- Balsammedica Sp. z o.o.
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Warsaw, Masovian Voivodeship, Pologne, 02-097
- Recrutement
- Centralny Szpital Kliniczny UCK WUM
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Basingstoke, Royaume-Uni, RG249NA
- Recrutement
- Basingstoke and North Hampshire Hospital
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Cottingham, Royaume-Uni, HU165JQ
- Recrutement
- Castle Hill Hospital
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Dudley, Royaume-Uni, DY12HQ
- Recrutement
- Russells Hall Hospital
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Dundonald, Royaume-Uni, BT161RH
- Recrutement
- Ulster Hospital
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Glasgow, Royaume-Uni, G40SF
- Recrutement
- Glasgow Royal Infirmary
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Swindon, Royaume-Uni, SN36BB
- Recrutement
- Great Western Hospitals
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Greater London
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Harefield, Greater London, Royaume-Uni, UB96JH
- Recrutement
- Harefield Hospital
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Hampshire
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Southampton, Hampshire, Royaume-Uni, SO166YD
- Recrutement
- Southampton General Hospital
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Scotland
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Glasgow, Scotland, Royaume-Uni, G514TF
- Recrutement
- Queen Elizabeth University Hospital
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Alabama
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Alexander City, Alabama, États-Unis, 35010
- Recrutement
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, États-Unis, 35233
- Recrutement
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, États-Unis, 85741
- Retiré
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, États-Unis, 90211
- Recrutement
- National Heart Institute
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, États-Unis, 92350
- Recrutement
- Nutrition Research Center (SPH)
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Los Angeles, California, États-Unis, 90033
- Recrutement
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, États-Unis, 90095
- Recrutement
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, États-Unis, 92868
- Recrutement
- University of California, Irvine Medical Center
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Sacramento, California, États-Unis, 95817
- Recrutement
- UC Davis Health
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Sacramento, California, États-Unis, 95816
- Recrutement
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, États-Unis, 92123
- Recrutement
- San Diego Cardiac Center
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San Francisco, California, États-Unis, 94109
- Recrutement
- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, États-Unis, 95051
- Recrutement
- Kaiser Permanente Santa Clara
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Stanford, California, États-Unis, 94303
- Recrutement
- Stanford University Hospital / Stanford Health Care
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Torrance, California, États-Unis, 90502
- Recrutement
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Recrutement
- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, États-Unis, 06606
- Recrutement
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, États-Unis, 06102
- Recrutement
- Hartford Hospital
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New Haven, Connecticut, États-Unis, 06519
- Recrutement
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, États-Unis, 33756
- Recrutement
- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, États-Unis, 33308
- Recrutement
- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, États-Unis, 33351
- Recrutement
- South Florida Research Solutions, LLC
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Jacksonville, Florida, États-Unis, 32209
- Recrutement
- UF Health Jacksonville
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Miami Beach, Florida, États-Unis, 33140
- Recrutement
- Broward Research Center
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Ocala, Florida, États-Unis, 34471
- Recrutement
- Ocala Cardiovascular Research
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Orlando, Florida, États-Unis, 32803
- Recrutement
- AdventHealth
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Tampa, Florida, États-Unis, 33606
- Recrutement
- USF Health South Tampa Center for Advanced Healthcare
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Georgia
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Atlanta, Georgia, États-Unis, 30303
- Recrutement
- Grady Health System
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Atlanta, Georgia, États-Unis, 30322
- Recrutement
- Emory Clinic
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Atlanta, Georgia, États-Unis, 30309
- Recrutement
- Piedmont Atlanta Hospital
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Fayetteville, Georgia, États-Unis, 30214
- Recrutement
- Piedmont Fayette Hospital
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Recrutement
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, États-Unis, 60540
- Recrutement
- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, États-Unis, 46321
- Recrutement
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, États-Unis, 47630
- Recrutement
- Deaconess Heart Group
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Richmond, Indiana, États-Unis, 47374
- Recrutement
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- Recrutement
- The University of Kansas Medical Center
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Overland Park, Kansas, États-Unis, 66211
- Recrutement
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Recrutement
- University Medical Center New Orleans
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Maine
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Bangor, Maine, États-Unis, 04401
- Recrutement
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Recrutement
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02111
- Recrutement
- Tufts Medical Center
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Recrutement
- Henry Ford Hospital
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Missouri
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Independence, Missouri, États-Unis, 64057
- Retiré
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, États-Unis, 64111
- Recrutement
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University Center for Advanced Medicine
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St Louis, Missouri, États-Unis, 63136
- Retiré
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, États-Unis, 68198
- Recrutement
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, États-Unis, 08807
- Recrutement
- Advanced Heart Care, LLC
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Eatontown, New Jersey, États-Unis, 07724
- Recrutement
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, États-Unis, 12205
- Recrutement
- Capital Cardiology Associates
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Manhasset, New York, États-Unis, 11030
- Recrutement
- Northwell Health North Shore University Hospital
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New York, New York, États-Unis, 10029
- Recrutement
- Mount Sinai Hospital
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New York, New York, États-Unis, 10032
- Recrutement
- Columbia University Medical Center / New York - Presbyterian
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The Bronx, New York, États-Unis, 10467
- Recrutement
- Montefiore Medical Center (Moses Campus)
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North Carolina
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Cary, North Carolina, États-Unis, 27518
- Recrutement
- WakeMed Heart & Vascular - Cary Cardiology
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Chapel Hill, North Carolina, États-Unis, 27599-7064
- Recrutement
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Hospital
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Greensboro, North Carolina, États-Unis, 27401
- Recrutement
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
-
Winston-Salem, North Carolina, États-Unis, 27157
- Recrutement
- Wake Forest University Health Sciences
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45219
- Recrutement
- The Lindner Research Center at the Christ Hospital
-
Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, États-Unis, 44195
- Recrutement
- Cleveland Clinic
-
Marion, Ohio, États-Unis, 43302
- Retiré
- K&R Research LLC
-
Sandusky, Ohio, États-Unis, 44870
- Retiré
- University of Hospitals North Ohio Heart
-
-
Oklahoma
-
Tulsa, Oklahoma, États-Unis, 74127
- Recrutement
- Oklahoma State University Center for Health Sciences
-
-
Oregon
-
Portland, Oregon, États-Unis, 97239
- Recrutement
- Oregon Health and Science University
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, États-Unis, 17011
- Recrutement
- Capital Area Research, LLC
-
Hershey, Pennsylvania, États-Unis, 17033
- Recrutement
- Penn State Health Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, États-Unis, 19104
- Recrutement
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
-
-
South Carolina
-
Charleston, South Carolina, États-Unis, 29425
- Recrutement
- Medical University of South Carolina - Gazes Research Institute
-
-
South Dakota
-
Rapid City, South Dakota, États-Unis, 57701
- Recrutement
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
-
-
Tennessee
-
Germantown, Tennessee, États-Unis, 38138
- Recrutement
- Stern Cardiovascular Foundation, Inc.
-
Knoxville, Tennessee, États-Unis, 37934
- Recrutement
- Tennova Healthcare-Turkey Creek Medical Center
-
Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt University Medical Center
-
Tullahoma, Tennessee, États-Unis, 37388
- Recrutement
- Tennessee Center for Clinical Trials
-
-
Texas
-
Dallas, Texas, États-Unis, 75246
- Recrutement
- Baylor University Medical Center
-
Dallas, Texas, États-Unis, 75390
- Recrutement
- The University of Texas Southwestern Medical Center
-
El Paso, Texas, États-Unis, 79902
- Retiré
- Medresearch Inc
-
Galveston, Texas, États-Unis, 77555
- Recrutement
- University of Texas Medical Branch - UTMB
-
Houston, Texas, États-Unis, 77030
- Recrutement
- CHI St. Luke's Health Baylor College of Medicine Medical Center
-
Plano, Texas, États-Unis, 75093
- Recrutement
- Baylor Scott & White Medical Center- The Hearth Hospital
-
-
Utah
-
Murray, Utah, États-Unis, 84107
- Recrutement
- Intermountain Medical Center
-
Salt Lake City, Utah, États-Unis, 84132
- Recrutement
- University of Utah Health
-
-
Virginia
-
Norfolk, Virginia, États-Unis, 23507
- Retiré
- Sentara Norfolk General Hospital
-
-
Washington
-
Spokane, Washington, États-Unis, 99204
- Recrutement
- Providence Advanced Heart Disease and Transplant
-
-
Wisconsin
-
Milwaukee, Wisconsin, États-Unis, 53226
- Recrutement
- Medical College of Wisconsin / Froedtert Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to the first event of CV death or HF event
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Cytokinetics MD, Cytokinetics
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 décembre 2024
Achèvement primaire (Estimé)
1 septembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
3 décembre 2024
Première soumission répondant aux critères de contrôle qualité
13 décembre 2024
Première publication (Réel)
16 décembre 2024
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 octobre 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CY 1033
- 2024-519219-32-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .