Onderzoek met Omecamtiv Mecarbil (CK-1827452) voor de behandeling van chronisch hartfalen met een ernstig verminderde ejectiefractie (COMET-HF)
2 november 2026 bijgewerkt door: Cytokinetics
Een multicenter, dubbelblinde, gerandomiseerde, placebogecontroleerde studie om de werkzaamheid en veiligheid van Omecamtiv Mecarbil te beoordelen bij patiënten met symptomatisch hartfalen met een ernstig verminderde ejectiefractie (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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
1800
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Cytokinetics MD
- Telefoonnummer: (650) 624-2929
- E-mail: medicalaffairs@cytokinetics.com
Studie Locaties
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
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- Mazankowski Alberta Heart Institute / University of Alberta Hospital
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British Columbia
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Kelowna, British Columbia, Canada, V1Y1T2
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- Kelowna General Hospital
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Surrey, British Columbia, Canada, V3V0C6
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- SMH - Cardiology Clinical Trials Inc.
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Vancouver, British Columbia, Canada, V6Z1Y6
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- St. Paul's Hospital
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Victoria, British Columbia, Canada, V8R1B2
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- Victoria Heart Institute Foundation
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Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
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- St. Boniface Hospital
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
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- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A5A5
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- London Health Sciences Centre
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Oakville, Ontario, Canada, L6M0L8
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- Oakville Trafalgar Memorial Hospital - Halton Healthcare
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Toronto, Ontario, Canada, M4N1J7
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- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B1W8
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- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G2C4
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- UHN-Toronto General Hospital
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Quebec
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Montreal, Quebec, Canada, H1T1C8
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- Montreal Heart Institute
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Sherbrooke, Quebec, Canada, J1L0H8
- Ingetrokken
- Diex Recherche Sherbrooke
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Terrebonne, Quebec, Canada, J6V 2H2
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- CISSSL - Hopital Pierre-Le Gardeur
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Haikou, China, 570311
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- Hainan General Hospital
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Hengyang, China, 421001
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- The First Affiliated Hospital of University of South China
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100032
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- Peking University Third Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400014
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- Chongqing Emergency Medical Center
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Gansu
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Lanzhou, Gansu, China, 730030
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- Lanzhou University Second
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Guangdong
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Guangzhou, Guangdong, China, 511400
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- The Affiliated Panyu Central Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, China, 510120
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- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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Shenzhen, Guangdong, China, 518053
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- The University of Hong Kong-Shenzhen Hospital
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Guangxi
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Nanning, Guangxi, China, 530020
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- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, China, 150001
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- The First Affiliated Hospital of Harbin Medical University
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Henan
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Luoyang, Henan, China, 471031
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- The First Affiliated Hospital of Henan University of science and Technology
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Zhengzhou, Henan, China, 450052
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- The First Affiliated Hospital of Zhengzhou University
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Hunan
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Changsha, Hunan, China, 410011
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- People's Hospital of Hunan Province
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Inner Mongolia
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Chifeng, Inner Mongolia, China, 024005
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- Affiliated Hospital of Chifeng University
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Jiangsu
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Xuzhou, Jiangsu, China, 221002
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- The Affiliated Hospital of Xuzhou Medical University
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Yangzhou, Jiangsu, China, 225001
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- Northern Jiangsu People's Hospital
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Jilin
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Changchun, Jilin, China, 130033
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- China-Japan Union Hospital of Jilin University
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Shandong
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Heze, Shandong, China, 274002
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- Heze Municipal Hospital
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Jining, Shandong, China, 272029
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- Affiliated Hospital of Jining Medical University
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Shanxi
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Taiyuan, Shanxi, China, 030024
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- Shanxi Cardiovascular Hospital
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Yuncheng, Shanxi, China, 44000
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- Yuncheng Central Hospital
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Taizhou
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Linhai, Taizhou, China, 317000
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- Zhejiang Province Taizhou Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300457
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- Teda International Cardiovascular Hospital
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Tianjin, Tianjin Municipality, China, 300020
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- Tianjin Medical University General Hospital
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Duitsland, 69120
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- Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
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Bavaria
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München, Bavaria, Duitsland, 81377
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- LMU Klinikum - Medizinische Klinik und Poliklinik I
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Würzburg, Bavaria, Duitsland, 97078
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- 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, Duitsland, 20246
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- UKE, Klinik für Kardiologie
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Hamburg, Free and Hanseatic City of Hamburg, Duitsland, 20246
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- UKE, Klinik fur Kardiologie
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Germany
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Erfurt, Germany, Duitsland, 99089
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- Helios Klinikum Erfurt GmbH
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Jena, Germany, Duitsland, 07747
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- Universitaetsklinikum Jena
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Mainz, Germany, Duitsland, 55131
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- Marienhaus Klinikum Mainz GmbH
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Hesse
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Bad Nauheim, Hesse, Duitsland, 61231
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- Kerckhoff-Klinik GmbH
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Frankfurt am Main, Hesse, Duitsland, 60590
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- Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
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Langen, Hesse, Duitsland, 63225
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- Asklepios Klinik Langen-Seligenstadt GmbH
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Lower Saxony
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Göttingen, Lower Saxony, Duitsland, 37075
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- Universitaetsmedizin Goettingen
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Duitsland, 53127
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- Universitätsklinikum Bonn
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Saarland
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Homburg, Saarland, Duitsland, 66424
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- Uniklinikum Saarland
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Saxony
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Markkleeberg, Saxony, Duitsland, 04416
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- Dr. med. Jens Taggeselle
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrijk, 31059
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- Centre Hospitalier Universitaire de Toulouse
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Hauts-de-France
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Valenciennes, Hauts-de-France, Frankrijk, 59300
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- Polyclinique Vauban
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrijk, 35033
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- CHU de Rennes - Hôpital Pontchaillou
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Isère
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La Tronche, Isère, Frankrijk, 38700
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- Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
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Occitanie
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Montpellier, Occitanie, Frankrijk, 34295
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- 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, Frankrijk, 44277
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- L'Hôpital Privé Du Confluent
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Rhône
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Bron, Rhône, Frankrijk, 69677
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- Hospices Civils de Lyon - Hôpital Louis Pradel
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Var
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Toulon, Var, Frankrijk, 83100
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- 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, Frankrijk, 75010
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- Hôpital Lariboisière - APHP
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Paris, Île-de-France Region, Frankrijk, 75015
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- Hôpital Européen Georges Pompidou
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Paris, Île-de-France Region, Frankrijk, 75018
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- APHP - Hôpital Bichât
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Attica
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Athens, Attica, Griekenland, 11527
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- General Hospital of Athens ''G. Gennimatas''
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Athens, Attica, Griekenland, 11527
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- General Hospital of Athens ''Hippokratio''
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Athens, Attica, Griekenland, 14233
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- General Hospital of Nea Ionia ''Konstantopouleio-Patision''
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Chaïdári, Attica, Griekenland, 12462
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- University General Hospital ''ATTIKON'' - General Hospital of West Attica H
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Voula, Attica, Griekenland, 16673
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- General Hospital ''Asklepieio Voulas''
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Euboea
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Chalcis, Euboea, Griekenland, 34100
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- General Hospital of Chalkida
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Evros
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Alexandroupoli, Evros, Griekenland, 68100
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- University General Hospital of Alexandroupolis
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Larissa
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Larissa, Larissa, Griekenland, 41110
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- University General Hospital of Larissa
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Thessaloniki
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Efkarpia, Thessaloniki, Griekenland, 56403
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- Papageorgiou General Hospital of Thessaloniki
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Thessaloniki, Thessaloniki, Griekenland, 54636
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- AHEPA University General Hospital of Thessaloniki
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Cona, Italië, 44124
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- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Roma, Italië, 00163
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- IRCCS San Raffaele
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BS
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Brescia, BS, Italië, 25123
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- ASST Spedali Civili di Brescia
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Emilia-Romagna
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Rimini, Emilia-Romagna, Italië, 47923
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- Ospedale Infermi
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Lombardy
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Arzignano, Lombardy, Italië, 36071
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- Ospedale di Arzignano
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Bergamo, Lombardy, Italië, 24127
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- ASST Papa Giovanni XXIII
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Milan, Lombardy, Italië, 20138
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- Centro Cardiologico Monzino
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Sesto San Giovanni, Lombardy, Italië, 20099
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- IRCCS Multimedica
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MI
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Milan, MI, Italië, 20132
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- IRCCS Ospedale San Raffaele
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Province of Perugia
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Perugia, Province of Perugia, Italië, 06129
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- A.O. Perugia - Ospedale S.Maria della Misericordia
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Bialystok, Polen, 15276
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- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Krakow, Polen, 31202
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- Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
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Lodz, Polen, 90549
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- SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
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Lodz, Polen, 92213
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- SPZOZ Centralny Szpital Kliniczny UM w Lodzi
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Miechów, Polen, 32200
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- Szpital Sw. Anny w Miechowie
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Opole, Polen, 45401
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- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Polen, 61848
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- Uniwersytecki Szpital Kliniczny w Poznaniu
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Ruda Śląska, Polen, 41710
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- Poradnia AKA-MED Centrum Sp. z o.o.
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Torun, Polen, 87100
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- Wojewodzki Szpital Zespolony im. L. Rydygiera
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Świdnik, Polen, 21040
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- Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 01249
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- Balsammedica Sp. z o.o.
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Warsaw, Masovian Voivodeship, Polen, 02-097
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- Centralny Szpital Kliniczny UCK WUM
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A Coruña
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A Coruña, A Coruña, Spanje, 15006
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- Hospital Universitario A Coruña
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Santiago de Compostela, A Coruña, Spanje, 15706
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- Hospital Clinico Universitario de Santiago
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Barcelona
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Barcelona, Barcelona, Spanje, 08035
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- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona, Spanje, 08025
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- Hospital de la Santa Creu i Sant Pau
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L'Hospitalet de Llobregat, Barcelona, Spanje, 08907
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- Hospital Universitari de Bellvitge
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Jaen
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Úbeda, Jaen, Spanje, 23400
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- Hospital San Juan de la Cruz
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Lugo
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Lugo, Lugo, Spanje, 27003
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- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, Spanje, 28041
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- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Spanje, 28046
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- Hospital Universitario La Paz
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Majadahonda, Madrid, Spanje, 28222
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- Hospital Universitario Puerta de Hierro
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Murcia
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El Palmar, Murcia, Spanje, 30120
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- Hospital Universitario Virgen de La Arrixaca
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Pontevedra
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Vigo, Pontevedra, Spanje, 36312
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- CHUVI - H.U. Alvaro Cunqueiro
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Salamanca
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Salamanca, Salamanca, Spanje, 37007
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- Hospital Universitario de Salamanca
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Sevilla
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Seville, Sevilla, Spanje, 41013
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- Hospital Universitario Virgen del Rocío
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Tarragona
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Tarragona, Tarragona, Spanje, 43005
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- Hospital Universitari Joan XXIII de Tarragona
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Valencia
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Valencia, Valencia, Spanje, 46010
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- Hospital Clínico Universitario de Valencia
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Valencia, Valencia, Spanje, 46026
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- Hospital Universitari i Politecnic La Fe de Valencia
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Basingstoke, Verenigd Koninkrijk, RG249NA
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- Basingstoke and North Hampshire Hospital
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Cottingham, Verenigd Koninkrijk, HU165JQ
- Werving
- Castle Hill Hospital
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Dudley, Verenigd Koninkrijk, DY12HQ
- Werving
- Russells Hall Hospital
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Dundonald, Verenigd Koninkrijk, BT161RH
- Werving
- Ulster Hospital
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Glasgow, Verenigd Koninkrijk, G40SF
- Werving
- Glasgow Royal Infirmary
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Swindon, Verenigd Koninkrijk, SN36BB
- Werving
- Great Western Hospitals
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Greater London
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Harefield, Greater London, Verenigd Koninkrijk, UB96JH
- Werving
- Harefield Hospital
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Hampshire
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Southampton, Hampshire, Verenigd Koninkrijk, SO166YD
- Werving
- Southampton General Hospital
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Scotland
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Glasgow, Scotland, Verenigd Koninkrijk, G514TF
- Werving
- Queen Elizabeth University Hospital
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Alabama
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Alexander City, Alabama, Verenigde Staten, 35010
- Werving
- Advanced Cardiovascular, LLC
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Birmingham, Alabama, Verenigde Staten, 35233
- Werving
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Verenigde Staten, 85741
- Ingetrokken
- Pima Heart and Vascular Clinical Research
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California
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Beverly Hills, California, Verenigde Staten, 90211
- Werving
- National Heart Institute
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Health - Sulpizio Cardiovascular Center
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Loma Linda, California, Verenigde Staten, 92350
- Werving
- Nutrition Research Center (SPH)
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Los Angeles, California, Verenigde Staten, 90033
- Werving
- Keck Medical Center of USC (outpatient clinic)
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Los Angeles, California, Verenigde Staten, 90095
- Werving
- UCLA Medical Center Cardiovascular Clinic
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Orange, California, Verenigde Staten, 92868
- Werving
- University of California, Irvine Medical Center
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Sacramento, California, Verenigde Staten, 95817
- Werving
- UC Davis Health
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Sacramento, California, Verenigde Staten, 95816
- Werving
- Sutter Institute for Medical Research (SIMR)
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San Diego, California, Verenigde Staten, 92123
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- San Diego Cardiac Center
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San Francisco, California, Verenigde Staten, 94109
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- California Pacific Medical Center Van Ness Campus
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Santa Clara, California, Verenigde Staten, 95051
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- Kaiser Permanente Santa Clara
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Stanford, California, Verenigde Staten, 94303
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- Stanford University Hospital / Stanford Health Care
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Torrance, California, Verenigde Staten, 90502
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- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
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- Rocky Mountain Regional VA Medical Center
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten, 06606
- Werving
- Cardiology Associates of Fairfield County, P.C
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Hartford, Connecticut, Verenigde Staten, 06102
- Werving
- Hartford Hospital
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New Haven, Connecticut, Verenigde Staten, 06519
- Werving
- Yale New Haven Health Heart & Vascular Center Outpatient Services
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Florida
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Clearwater, Florida, Verenigde Staten, 33756
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- CHF Heart Clinical (Subject Visits & IP Shipments)
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Fort Lauderdale, Florida, Verenigde Staten, 33308
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- Holy Cross Medical Group - Cardiology Associates
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Hollywood, Florida, Verenigde Staten, 33351
- Werving
- South Florida Research Solutions, LLC
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Jacksonville, Florida, Verenigde Staten, 32209
- Werving
- UF Health Jacksonville
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Miami Beach, Florida, Verenigde Staten, 33140
- Werving
- Broward Research Center
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Ocala, Florida, Verenigde Staten, 34471
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- Ocala Cardiovascular Research
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Orlando, Florida, Verenigde Staten, 32803
- Werving
- AdventHealth
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Tampa, Florida, Verenigde Staten, 33606
- Werving
- USF Health South Tampa Center for Advanced Healthcare
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Tampa, Florida, Verenigde Staten, 33607
- Werving
- Saint Josephs Hospitals
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Werving
- Grady Health System
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Atlanta, Georgia, Verenigde Staten, 30322
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- Emory Clinic
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Atlanta, Georgia, Verenigde Staten, 30309
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- Piedmont Atlanta Hospital
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Fayetteville, Georgia, Verenigde Staten, 30214
- Werving
- Piedmont Fayette Hospital
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Werving
- The Queen's Medical Center - Punchbowl
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Illinois
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Naperville, Illinois, Verenigde Staten, 60540
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- Midwest Cardiovascular Institute
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Indiana
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Munster, Indiana, Verenigde Staten, 46321
- Werving
- Cardiovascular Research of Northwest Indiana, LLC.
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Newburgh, Indiana, Verenigde Staten, 47630
- Werving
- Deaconess Heart Group
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Richmond, Indiana, Verenigde Staten, 47374
- Werving
- Reid Physician Associates
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Werving
- The University of Kansas Medical Center
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Overland Park, Kansas, Verenigde Staten, 66211
- Werving
- AHMG Cardiology and Surgery
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Werving
- University Medical Center New Orleans
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Maine
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Bangor, Maine, Verenigde Staten, 04401
- Werving
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- Werving
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
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- Tufts Medical Center
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Werving
- Henry Ford Hospital
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Missouri
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Independence, Missouri, Verenigde Staten, 64057
- Ingetrokken
- Midwest Heart and Vascular Specialists, LLC
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Kansas City, Missouri, Verenigde Staten, 64111
- Werving
- Saint Luke's Hospital of Kansas City
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University Center for Advanced Medicine
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St Louis, Missouri, Verenigde Staten, 63136
- Ingetrokken
- St. Louis Heart and Vascular
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68198
- Werving
- University of Nebraska Medical Center
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New Jersey
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Bridgewater, New Jersey, Verenigde Staten, 08807
- Werving
- Advanced Heart Care, LLC
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Eatontown, New Jersey, Verenigde Staten, 07724
- Werving
- Monmouth Cardiology Associates, LLC
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New York
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Albany, New York, Verenigde Staten, 12205
- Werving
- Capital Cardiology Associates
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Manhasset, New York, Verenigde Staten, 11030
- Werving
- Northwell Health North Shore University Hospital
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New York, New York, Verenigde Staten, 10029
- Werving
- Mount Sinai Hospital
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University Medical Center / New York - Presbyterian
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Poughkeepsie, New York, Verenigde Staten, 12601
- Werving
- Hudson Valley Cardiovascular Practice
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The Bronx, New York, Verenigde Staten, 10467
- Werving
- Montefiore Medical Center (Moses Campus)
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North Carolina
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Cary, North Carolina, Verenigde Staten, 27518
- Werving
- WakeMed Heart & Vascular - Cary Cardiology
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7064
- Werving
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill
-
Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Hospital
-
Greensboro, North Carolina, Verenigde Staten, 27401
- Werving
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
-
Winston-Salem, North Carolina, Verenigde Staten, 27157
- Werving
- Wake Forest University Health Sciences
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 45219
- Werving
- The Lindner Research Center at the Christ Hospital
-
Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Verenigde Staten, 44195
- Werving
- Cleveland Clinic
-
Marion, Ohio, Verenigde Staten, 43302
- Ingetrokken
- K&R Research LLC
-
Sandusky, Ohio, Verenigde Staten, 44870
- Ingetrokken
- University of Hospitals North Ohio Heart
-
-
Oklahoma
-
Tulsa, Oklahoma, Verenigde Staten, 74127
- Werving
- Oklahoma State University Center for Health Sciences
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97239
- Werving
- Oregon Health and Science University
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Verenigde Staten, 17011
- Werving
- Capital Area Research, LLC
-
Hershey, Pennsylvania, Verenigde Staten, 17033
- Werving
- Penn State Health Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Werving
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
-
-
South Carolina
-
Charleston, South Carolina, Verenigde Staten, 29425
- Werving
- Medical University of South Carolina - Gazes Research Institute
-
-
South Dakota
-
Rapid City, South Dakota, Verenigde Staten, 57701
- Werving
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
-
-
Tennessee
-
Germantown, Tennessee, Verenigde Staten, 38138
- Werving
- Stern Cardiovascular Foundation, Inc.
-
Knoxville, Tennessee, Verenigde Staten, 37934
- Werving
- Tennova Healthcare-Turkey Creek Medical Center
-
Nashville, Tennessee, Verenigde Staten, 37232
- Werving
- Vanderbilt University Medical Center
-
Tullahoma, Tennessee, Verenigde Staten, 37388
- Werving
- Tennessee Center for Clinical Trials
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75246
- Werving
- Baylor University Medical Center
-
Dallas, Texas, Verenigde Staten, 75390
- Werving
- The University of Texas Southwestern Medical Center
-
El Paso, Texas, Verenigde Staten, 79902
- Ingetrokken
- Medresearch Inc
-
Galveston, Texas, Verenigde Staten, 77555
- Werving
- University of Texas Medical Branch - UTMB
-
Houston, Texas, Verenigde Staten, 77030
- Werving
- CHI St. Luke's Health Baylor College of Medicine Medical Center
-
Plano, Texas, Verenigde Staten, 75093
- Werving
- Baylor Scott & White Medical Center- The Hearth Hospital
-
-
Utah
-
Murray, Utah, Verenigde Staten, 84107
- Werving
- Intermountain Medical Center
-
Salt Lake City, Utah, Verenigde Staten, 84132
- Werving
- University of Utah Health
-
-
Virginia
-
Norfolk, Virginia, Verenigde Staten, 23507
- Ingetrokken
- Sentara Norfolk General Hospital
-
-
Washington
-
Spokane, Washington, Verenigde Staten, 99204
- Werving
- Providence Advanced Heart Disease and Transplant
-
-
Wisconsin
-
Milwaukee, Wisconsin, Verenigde Staten, 53226
- Werving
- Medical College of Wisconsin / Froedtert Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Placebo-vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to the first event of CV death or HF event
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Cytokinetics MD, Cytokinetics
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 december 2024
Primaire voltooiing (Geschat)
1 september 2027
Studie voltooiing (Geschat)
1 december 2027
Studieregistratiedata
Eerst ingediend
3 december 2024
Eerst ingediend dat voldeed aan de QC-criteria
13 december 2024
Eerst geplaatst (Werkelijk)
16 december 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 november 2026
Laatste update ingediend die voldeed aan QC-criteria
2 november 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CY 1033
- 2024-519219-32-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .