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Estudo com Omecamtiv Mecarbil (CK-1827452) para tratar insuficiência cardíaca crônica com fração de ejeção severamente reduzida (COMET-HF)

7 de outubro de 2026 atualizado por: Cytokinetics

Um ensaio multicêntrico, duplo-cego, randomizado e controlado por placebo para avaliar a eficácia e segurança do Omecamtiv Mecarbil em pacientes com insuficiência cardíaca sintomática com fração de ejeção gravemente reduzida (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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF).

Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed.

Estimated duration of participation: Up to 3 years.

Tipo de estudo

Intervencional

Inscrição (Estimado)

1800

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Alemanha
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Alemanha, 69120
        • Recrutamento
        • Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
    • Bavaria
      • München, Bavaria, Alemanha, 81377
        • Recrutamento
        • LMU Klinikum - Medizinische Klinik und Poliklinik I
      • Würzburg, Bavaria, Alemanha, 97078
        • Recrutamento
        • Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Alemanha, 20246
        • Recrutamento
        • UKE, Klinik für Kardiologie
      • Hamburg, Free and Hanseatic City of Hamburg, Alemanha, 20246
        • Recrutamento
        • UKE, Klinik fur Kardiologie
    • Germany
      • Erfurt, Germany, Alemanha, 99089
        • Recrutamento
        • Helios Klinikum Erfurt GmbH
      • Jena, Germany, Alemanha, 07747
        • Recrutamento
        • Universitaetsklinikum Jena
      • Mainz, Germany, Alemanha, 55131
        • Recrutamento
        • Marienhaus Klinikum Mainz GmbH
    • Hesse
      • Bad Nauheim, Hesse, Alemanha, 61231
        • Recrutamento
        • Kerckhoff-Klinik GmbH
      • Frankfurt am Main, Hesse, Alemanha, 60590
        • Recrutamento
        • Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
      • Langen, Hesse, Alemanha, 63225
        • Recrutamento
        • Asklepios Klinik Langen-Seligenstadt GmbH
    • Lower Saxony
      • Göttingen, Lower Saxony, Alemanha, 37075
        • Recrutamento
        • Universitaetsmedizin Goettingen
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Alemanha, 53127
        • Recrutamento
        • Universitätsklinikum Bonn
    • Saarland
      • Homburg, Saarland, Alemanha, 66424
        • Recrutamento
        • Uniklinikum Saarland
    • Saxony
      • Markkleeberg, Saxony, Alemanha, 04416
        • Recrutamento
        • Dr. med. Jens Taggeselle
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G2B7
        • Recrutamento
        • Mazankowski Alberta Heart Institute / University of Alberta Hospital
    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y1T2
        • Recrutamento
        • Kelowna General Hospital
      • Surrey, British Columbia, Canadá, V3V0C6
        • Recrutamento
        • SMH - Cardiology Clinical Trials Inc.
      • Vancouver, British Columbia, Canadá, V6Z1Y6
        • Recrutamento
        • St. Paul's Hospital
      • Victoria, British Columbia, Canadá, V8R1B2
        • Recrutamento
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R2H2A6
        • Recrutamento
        • St. Boniface Hospital
    • Ontario
      • Kingston, Ontario, Canadá, K7L 2V7
        • Recrutamento
        • Kingston Health Sciences Centre
      • London, Ontario, Canadá, N6A5A5
        • Recrutamento
        • London Health Sciences Centre
      • Oakville, Ontario, Canadá, L6M0L8
        • Recrutamento
        • Oakville Trafalgar Memorial Hospital - Halton Healthcare
      • Toronto, Ontario, Canadá, M4N1J7
        • Recrutamento
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canadá, M5B1W8
        • Recrutamento
        • St. Michael's Hospital
      • Toronto, Ontario, Canadá, M5G2C4
        • Recrutamento
        • UHN-Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canadá, H1T1C8
        • Recrutamento
        • Montreal Heart Institute
      • Sherbrooke, Quebec, Canadá, J1L0H8
        • Retirado
        • Diex Recherche Sherbrooke
      • Terrebonne, Quebec, Canadá, J6V 2H2
        • Recrutamento
        • CISSSL - Hopital Pierre-Le Gardeur
  • China
      • Haikou, China, 570311
        • Recrutamento
        • Hainan General Hospital
      • Hengyang, China, 421001
        • Recrutamento
        • The First Affiliated Hospital of University of South China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100032
        • Recrutamento
        • Peking University Third Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400014
        • Recrutamento
        • Chongqing Emergency Medical Center
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recrutamento
        • Lanzhou University Second
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Recrutamento
        • The Affiliated Panyu Central Hospital of Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518053
        • Recrutamento
        • The University of Hong Kong-Shenzhen Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530020
        • Recrutamento
        • The First Affiliated Hospital of Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recrutamento
        • The First Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang, Henan, China, 471031
        • Recrutamento
        • The First Affiliated Hospital of Henan University of science and Technology
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recrutamento
        • People's Hospital of Hunan Province
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024005
        • Recrutamento
        • Affiliated Hospital of Chifeng University
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • Recrutamento
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, Jiangsu, China, 225001
        • Recrutamento
        • Northern Jiangsu People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recrutamento
        • China-Japan Union Hospital of Jilin University
    • Shandong
      • Heze, Shandong, China, 274002
        • Recrutamento
        • Heze Municipal Hospital
      • Jining, Shandong, China, 272029
        • Recrutamento
        • Affiliated Hospital of Jining Medical University
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Recrutamento
        • Shanxi Cardiovascular Hospital
      • Yuncheng, Shanxi, China, 44000
        • Recrutamento
        • Yuncheng Central Hospital
    • Taizhou
      • Linhai, Taizhou, China, 317000
        • Recrutamento
        • Zhejiang Province Taizhou Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300457
        • Recrutamento
        • Teda International Cardiovascular Hospital
      • Tianjin, Tianjin Municipality, China, 300020
        • Recrutamento
        • Tianjin Medical University General Hospital
  • Espanha
    • A Coruña
      • A Coruña, A Coruña, Espanha, 15006
        • Recrutamento
        • Hospital Universitario A Coruña
      • Santiago de Compostela, A Coruña, Espanha, 15706
        • Recrutamento
        • Hospital Clinico Universitario de Santiago
    • Barcelona
      • Barcelona, Barcelona, Espanha, 08035
        • Recrutamento
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona, Espanha, 08025
        • Recrutamento
        • Hospital de la Santa Creu i Sant Pau
      • L'Hospitalet de Llobregat, Barcelona, Espanha, 08907
        • Recrutamento
        • Hospital Universitari de Bellvitge
    • Jaen
      • Úbeda, Jaen, Espanha, 23400
        • Recrutamento
        • Hospital San Juan de la Cruz
    • Lugo
      • Lugo, Lugo, Espanha, 27003
        • Recrutamento
        • Hospital Universitario Lucus Augusti
    • Madrid
      • Madrid, Madrid, Espanha, 28041
        • Recrutamento
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Espanha, 28046
        • Recrutamento
        • Hospital Universitario La Paz
      • Majadahonda, Madrid, Espanha, 28222
        • Recrutamento
        • Hospital Universitario Puerta de Hierro
    • Murcia
      • El Palmar, Murcia, Espanha, 30120
        • Recrutamento
        • Hospital Universitario Virgen de La Arrixaca
    • Pontevedra
      • Vigo, Pontevedra, Espanha, 36312
        • Recrutamento
        • CHUVI - H.U. Alvaro Cunqueiro
    • Salamanca
      • Salamanca, Salamanca, Espanha, 37007
        • Recrutamento
        • Hospital Universitario de Salamanca
    • Sevilla
      • Seville, Sevilla, Espanha, 41013
        • Recrutamento
        • Hospital Universitario Virgen del Rocío
    • Tarragona
      • Tarragona, Tarragona, Espanha, 43005
        • Recrutamento
        • Hospital Universitari Joan XXIII de Tarragona
    • Valencia
      • Valencia, Valencia, Espanha, 46010
        • Recrutamento
        • Hospital Clínico Universitario de Valencia
      • Valencia, Valencia, Espanha, 46026
        • Recrutamento
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Estados Unidos
    • Alabama
      • Alexander City, Alabama, Estados Unidos, 35010
        • Recrutamento
        • Advanced Cardiovascular, LLC
      • Birmingham, Alabama, Estados Unidos, 35233
        • Recrutamento
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85741
        • Retirado
        • Pima Heart and Vascular Clinical Research
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Recrutamento
        • National Heart Institute
      • La Jolla, California, Estados Unidos, 92037
        • Recrutamento
        • UC San Diego Health - Sulpizio Cardiovascular Center
      • Loma Linda, California, Estados Unidos, 92350
        • Recrutamento
        • Nutrition Research Center (SPH)
      • Los Angeles, California, Estados Unidos, 90033
        • Recrutamento
        • Keck Medical Center of USC (outpatient clinic)
      • Los Angeles, California, Estados Unidos, 90095
        • Recrutamento
        • UCLA Medical Center Cardiovascular Clinic
      • Orange, California, Estados Unidos, 92868
        • Recrutamento
        • University of California, Irvine Medical Center
      • Sacramento, California, Estados Unidos, 95817
        • Recrutamento
        • UC Davis Health
      • Sacramento, California, Estados Unidos, 95816
        • Recrutamento
        • Sutter Institute for Medical Research (SIMR)
      • San Diego, California, Estados Unidos, 92123
        • Recrutamento
        • San Diego Cardiac Center
      • San Francisco, California, Estados Unidos, 94109
        • Recrutamento
        • California Pacific Medical Center Van Ness Campus
      • Santa Clara, California, Estados Unidos, 95051
        • Recrutamento
        • Kaiser Permanente Santa Clara
      • Stanford, California, Estados Unidos, 94303
        • Recrutamento
        • Stanford University Hospital / Stanford Health Care
      • Torrance, California, Estados Unidos, 90502
        • Recrutamento
        • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Recrutamento
        • Rocky Mountain Regional VA Medical Center
    • Connecticut
      • Bridgeport, Connecticut, Estados Unidos, 06606
        • Recrutamento
        • Cardiology Associates of Fairfield County, P.C
      • Hartford, Connecticut, Estados Unidos, 06102
        • Recrutamento
        • Hartford Hospital
      • New Haven, Connecticut, Estados Unidos, 06519
        • Recrutamento
        • Yale New Haven Health Heart & Vascular Center Outpatient Services
    • Florida
      • Clearwater, Florida, Estados Unidos, 33756
        • Recrutamento
        • CHF Heart Clinical (Subject Visits & IP Shipments)
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Recrutamento
        • Holy Cross Medical Group - Cardiology Associates
      • Hollywood, Florida, Estados Unidos, 33351
        • Recrutamento
        • South Florida Research Solutions, LLC
      • Jacksonville, Florida, Estados Unidos, 32209
        • Recrutamento
        • UF Health Jacksonville
      • Miami Beach, Florida, Estados Unidos, 33140
        • Recrutamento
        • Broward Research Center
      • Ocala, Florida, Estados Unidos, 34471
        • Recrutamento
        • Ocala Cardiovascular Research
      • Orlando, Florida, Estados Unidos, 32803
        • Recrutamento
        • AdventHealth
      • Tampa, Florida, Estados Unidos, 33606
        • Recrutamento
        • USF Health South Tampa Center for Advanced Healthcare
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Recrutamento
        • Grady Health System
      • Atlanta, Georgia, Estados Unidos, 30322
        • Recrutamento
        • Emory Clinic
      • Atlanta, Georgia, Estados Unidos, 30309
        • Recrutamento
        • Piedmont Atlanta Hospital
      • Fayetteville, Georgia, Estados Unidos, 30214
        • Recrutamento
        • Piedmont Fayette Hospital
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Recrutamento
        • The Queen's Medical Center - Punchbowl
    • Illinois
      • Naperville, Illinois, Estados Unidos, 60540
        • Recrutamento
        • Midwest Cardiovascular Institute
    • Indiana
      • Munster, Indiana, Estados Unidos, 46321
        • Recrutamento
        • Cardiovascular Research of Northwest Indiana, LLC.
      • Newburgh, Indiana, Estados Unidos, 47630
        • Recrutamento
        • Deaconess Heart Group
      • Richmond, Indiana, Estados Unidos, 47374
        • Recrutamento
        • Reid Physician Associates
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Recrutamento
        • The University of Kansas Medical Center
      • Overland Park, Kansas, Estados Unidos, 66211
        • Recrutamento
        • AHMG Cardiology and Surgery
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Recrutamento
        • University Medical Center New Orleans
    • Maine
      • Bangor, Maine, Estados Unidos, 04401
        • Recrutamento
        • Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Recrutamento
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Recrutamento
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Hospital
    • Missouri
      • Independence, Missouri, Estados Unidos, 64057
        • Retirado
        • Midwest Heart and Vascular Specialists, LLC
      • Kansas City, Missouri, Estados Unidos, 64111
        • Recrutamento
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, Estados Unidos, 63110
        • Recrutamento
        • Washington University Center for Advanced Medicine
      • St Louis, Missouri, Estados Unidos, 63136
        • Retirado
        • St. Louis Heart and Vascular
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198
        • Recrutamento
        • University of Nebraska Medical Center
    • New Jersey
      • Bridgewater, New Jersey, Estados Unidos, 08807
        • Recrutamento
        • Advanced Heart Care, LLC
      • Eatontown, New Jersey, Estados Unidos, 07724
        • Recrutamento
        • Monmouth Cardiology Associates, LLC
    • New York
      • Albany, New York, Estados Unidos, 12205
        • Recrutamento
        • Capital Cardiology Associates
      • Manhasset, New York, Estados Unidos, 11030
        • Recrutamento
        • Northwell Health North Shore University Hospital
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Mount Sinai Hospital
      • New York, New York, Estados Unidos, 10032
        • Recrutamento
        • Columbia University Medical Center / New York - Presbyterian
      • The Bronx, New York, Estados Unidos, 10467
        • Recrutamento
        • Montefiore Medical Center (Moses Campus)
    • North Carolina
      • Cary, North Carolina, Estados Unidos, 27518
        • Recrutamento
        • WakeMed Heart & Vascular - Cary Cardiology
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7064
        • Recrutamento
        • Clinical and Translational Research Center - University of North Carolina at Chapel Hill
      • Durham, North Carolina, Estados Unidos, 27710
        • Recrutamento
        • Duke University Hospital
      • Greensboro, North Carolina, Estados Unidos, 27401
        • Recrutamento
        • Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Recrutamento
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Recrutamento
        • The Lindner Research Center at the Christ Hospital
      • Cleveland, Ohio, Estados Unidos, 44106
        • Recrutamento
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, Estados Unidos, 44195
        • Recrutamento
        • Cleveland Clinic
      • Marion, Ohio, Estados Unidos, 43302
        • Retirado
        • K&R Research LLC
      • Sandusky, Ohio, Estados Unidos, 44870
        • Retirado
        • University of Hospitals North Ohio Heart
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74127
        • Recrutamento
        • Oklahoma State University Center for Health Sciences
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Recrutamento
        • Oregon Health and Science University
    • Pennsylvania
      • Camp Hill, Pennsylvania, Estados Unidos, 17011
        • Recrutamento
        • Capital Area Research, LLC
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Recrutamento
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Recrutamento
        • Medical University of South Carolina - Gazes Research Institute
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Recrutamento
        • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
    • Tennessee
      • Germantown, Tennessee, Estados Unidos, 38138
        • Recrutamento
        • Stern Cardiovascular Foundation, Inc.
      • Knoxville, Tennessee, Estados Unidos, 37934
        • Recrutamento
        • Tennova Healthcare-Turkey Creek Medical Center
      • Nashville, Tennessee, Estados Unidos, 37232
        • Recrutamento
        • Vanderbilt University Medical Center
      • Tullahoma, Tennessee, Estados Unidos, 37388
        • Recrutamento
        • Tennessee Center for Clinical Trials
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Recrutamento
        • Baylor University Medical Center
      • Dallas, Texas, Estados Unidos, 75390
        • Recrutamento
        • The University of Texas Southwestern Medical Center
      • El Paso, Texas, Estados Unidos, 79902
        • Retirado
        • Medresearch Inc
      • Galveston, Texas, Estados Unidos, 77555
        • Recrutamento
        • University of Texas Medical Branch - UTMB
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
      • Plano, Texas, Estados Unidos, 75093
        • Recrutamento
        • Baylor Scott & White Medical Center- The Hearth Hospital
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Recrutamento
        • Intermountain Medical Center
      • Salt Lake City, Utah, Estados Unidos, 84132
        • Recrutamento
        • University of Utah Health
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23507
        • Retirado
        • Sentara Norfolk General Hospital
    • Washington
      • Spokane, Washington, Estados Unidos, 99204
        • Recrutamento
        • Providence Advanced Heart Disease and Transplant
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Recrutamento
        • Medical College of Wisconsin / Froedtert Hospital
  • França
    • Haute-Garonne
      • Toulouse, Haute-Garonne, França, 31059
        • Recrutamento
        • Centre Hospitalier Universitaire de Toulouse
    • Hauts-de-France
      • Valenciennes, Hauts-de-France, França, 59300
        • Recrutamento
        • Polyclinique Vauban
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, França, 35033
        • Recrutamento
        • CHU de Rennes - Hôpital Pontchaillou
    • Isère
      • La Tronche, Isère, França, 38700
        • Recrutamento
        • Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
    • Occitanie
      • Montpellier, Occitanie, França, 34295
        • Recrutamento
        • CHU de Montpellier- Hôpital Arnaud de Villeneuve
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, França, 44277
        • Recrutamento
        • L'Hôpital Privé Du Confluent
    • Rhône
      • Bron, Rhône, França, 69677
        • Recrutamento
        • Hospices Civils de Lyon - Hôpital Louis Pradel
    • Var
      • Toulon, Var, França, 83100
        • Recrutamento
        • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
    • Île-de-France Region
      • Paris, Île-de-France Region, França, 75010
        • Recrutamento
        • Hôpital Lariboisière - APHP
      • Paris, Île-de-France Region, França, 75015
        • Recrutamento
        • Hôpital Européen Georges Pompidou
      • Paris, Île-de-France Region, França, 75018
        • Recrutamento
        • APHP - Hôpital Bichât
  • Grécia
    • Attica
      • Athens, Attica, Grécia, 11527
        • Recrutamento
        • General Hospital of Athens ''G. Gennimatas''
      • Athens, Attica, Grécia, 11527
        • Recrutamento
        • General Hospital of Athens ''Hippokratio''
      • Athens, Attica, Grécia, 14233
        • Recrutamento
        • General Hospital of Nea Ionia ''Konstantopouleio-Patision''
      • Chaïdári, Attica, Grécia, 12462
        • Recrutamento
        • University General Hospital ''ATTIKON'' - General Hospital of West Attica H
      • Voula, Attica, Grécia, 16673
        • Recrutamento
        • General Hospital ''Asklepieio Voulas''
    • Euboea
      • Chalcis, Euboea, Grécia, 34100
        • Recrutamento
        • General Hospital of Chalkida
    • Evros
      • Alexandroupoli, Evros, Grécia, 68100
        • Recrutamento
        • University General Hospital of Alexandroupolis
    • Larissa
      • Larissa, Larissa, Grécia, 41110
        • Recrutamento
        • University General Hospital of Larissa
    • Thessaloniki
      • Efkarpia, Thessaloniki, Grécia, 56403
        • Recrutamento
        • Papageorgiou General Hospital of Thessaloniki
      • Thessaloniki, Thessaloniki, Grécia, 54636
        • Recrutamento
        • AHEPA University General Hospital of Thessaloniki
  • Itália
      • Cona, Itália, 44124
        • Recrutamento
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
      • Roma, Itália, 00163
        • Recrutamento
        • IRCCS San Raffaele
    • BS
      • Brescia, BS, Itália, 25123
        • Recrutamento
        • ASST Spedali Civili di Brescia
    • Emilia-Romagna
      • Rimini, Emilia-Romagna, Itália, 47923
        • Recrutamento
        • Ospedale Infermi
    • Lombardy
      • Arzignano, Lombardy, Itália, 36071
        • Recrutamento
        • Ospedale di Arzignano
      • Bergamo, Lombardy, Itália, 24127
        • Recrutamento
        • ASST Papa Giovanni XXIII
      • Milan, Lombardy, Itália, 20138
        • Recrutamento
        • Centro Cardiologico Monzino
      • Sesto San Giovanni, Lombardy, Itália, 20099
        • Recrutamento
        • IRCCS Multimedica
    • MI
      • Milan, MI, Itália, 20132
        • Recrutamento
        • IRCCS Ospedale San Raffaele
    • Province of Perugia
      • Perugia, Province of Perugia, Itália, 06129
        • Recrutamento
        • A.O. Perugia - Ospedale S.Maria della Misericordia
  • Polônia
      • Bialystok, Polônia, 15276
        • Recrutamento
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Krakow, Polônia, 31202
        • Recrutamento
        • Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
      • Lodz, Polônia, 90549
        • Recrutamento
        • SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
      • Lodz, Polônia, 92213
        • Recrutamento
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
      • Miechów, Polônia, 32200
        • Recrutamento
        • Szpital Sw. Anny w Miechowie
      • Opole, Polônia, 45401
        • Recrutamento
        • Uniwersytecki Szpital Kliniczny w Opolu
      • Poznan, Polônia, 61848
        • Recrutamento
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Ruda Śląska, Polônia, 41710
        • Recrutamento
        • Poradnia AKA-MED Centrum Sp. z o.o.
      • Torun, Polônia, 87100
        • Recrutamento
        • Wojewodzki Szpital Zespolony im. L. Rydygiera
      • Świdnik, Polônia, 21040
        • Recrutamento
        • Tomasz Blicharski Lubelskie Centrum Diagnostyczne
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polônia, 01249
        • Recrutamento
        • Balsammedica Sp. z o.o.
      • Warsaw, Masovian Voivodeship, Polônia, 02-097
        • Recrutamento
        • Centralny Szpital Kliniczny UCK WUM
  • Reino Unido
      • Basingstoke, Reino Unido, RG249NA
        • Recrutamento
        • Basingstoke and North Hampshire Hospital
      • Cottingham, Reino Unido, HU165JQ
        • Recrutamento
        • Castle Hill Hospital
      • Dudley, Reino Unido, DY12HQ
        • Recrutamento
        • Russells Hall Hospital
      • Dundonald, Reino Unido, BT161RH
        • Recrutamento
        • Ulster Hospital
      • Glasgow, Reino Unido, G40SF
        • Recrutamento
        • Glasgow Royal Infirmary
      • Swindon, Reino Unido, SN36BB
        • Recrutamento
        • Great Western Hospitals
    • Greater London
      • Harefield, Greater London, Reino Unido, UB96JH
        • Recrutamento
        • Harefield Hospital
    • Hampshire
      • Southampton, Hampshire, Reino Unido, SO166YD
        • Recrutamento
        • Southampton General Hospital
    • Scotland
      • Glasgow, Scotland, Reino Unido, G514TF
        • Recrutamento
        • Queen Elizabeth University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: Omecamtiv Mecarbil (OM)

Oral Tablet
Comparador de 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.
Medicamento: Placebo

Oral Tablet

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time to the first event of CV death or HF event
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cytokinetics

Investigadores

  • Diretor de estudo: Cytokinetics MD, Cytokinetics

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de dezembro de 2024

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

3 de dezembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de dezembro de 2024

Primeira postagem (Real)

16 de dezembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de outubro de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CY 1033
  • 2024-519219-32-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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