Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
NCT ID: NCT06736574
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1800 participants
INTERVENTIONAL
2024-12-19
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Omecamtiv Mecarbil (OM)
Oral Tablet
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.
Placebo
Oral Tablet
Interventions
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Omecamtiv Mecarbil (OM)
Oral Tablet
Placebo
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening
* Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
* Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg
Exclusion Criteria
* Have AFF on the screening ECG and are currently taking digoxin
* Have had acute coronary syndrome, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization 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
* 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 previously received omecamtiv mecarbil
* 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
18 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Cytokinetics MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Nutrition Research Center (SPH)
Loma Linda, California, United States
Keck Medical Center of USC (outpatient clinic)
Los Angeles, California, United States
UCLA Medical Center Cardiovascular Clinic
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sutter Institute for Medical Research (SIMR)
Sacramento, California, United States
UC Davis Health
Sacramento, California, United States
San Diego Cardiac Center
San Diego, California, United States
California Pacific Medical Center Van Ness Campus
San Francisco, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Stanford University Hospital / Stanford Health Care
Stanford, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Cardiology Associates of Fairfield County, P.C
Bridgeport, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Health Heart & Vascular Center Outpatient Services
New Haven, Connecticut, United States
CHF Heart Clinical (Subject Visits & IP Shipments)
Clearwater, Florida, United States
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale, Florida, United States
South Florida Research Solutions, LLC
Hollywood, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Broward Research Center
Miami Beach, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
AdventHealth
Orlando, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Emory Clinic
Atlanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
The Queen's Medical Center - Punchbowl
Honolulu, Hawaii, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana, United States
Deaconess Heart Group
Newburgh, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
AHMG Cardiology and Surgery
Overland Park, Kansas, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Midwest Heart and Vascular Specialists, LLC
Independence, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University Center for Advanced Medicine
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
Monmouth Cardiology Associates, LLC
Eatontown, New Jersey, United States
Capital Cardiology Associates
Albany, New York, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center / New York - Presbyterian
New York, New York, United States
Montefiore Medical Center (Moses Campus)
The Bronx, New York, United States
WakeMed Heart & Vascular - Cary Cardiology
Cary, North Carolina, United States
Clinical and Translational Research Center - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
K&R Research LLC
Marion, Ohio, United States
University of Hospitals North Ohio Heart
Sandusky, Ohio, United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina - Gazes Research Institute
Charleston, South Carolina, United States
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Medresearch Inc
El Paso, Texas, United States
University of Texas Medical Branch - UTMB
Galveston, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, United States
Baylor Scott & White Medical Center- The Hearth Hospital
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Providence Advanced Heart Disease and Transplant
Spokane, Washington, United States
Medical College of Wisconsin / Froedtert Hospital
Milwaukee, Wisconsin, United States
Mazankowski Alberta Heart Institute / University of Alberta Hospital
Edmonton, Alberta, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
SMH - Cardiology Clinical Trials Inc.
Surrey, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Oakville Trafalgar Memorial Hospital - Halton Healthcare
Oakville, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
UHN-Toronto General Hospital
Toronto, Ontario, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire de Toulouse
Toulouse, Haute-Garonne, France
Polyclinique Vauban
Valenciennes, Hauts-de-France, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
La Tronche, Isère, France
CHU de Montpellier- Hôpital Arnaud de Villeneuve
Montpellier, Occitanie, France
L'Hôpital Privé Du Confluent
Nantes, Pays de la Loire Region, France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
Toulon, Var, France
Hôpital Lariboisière - APHP
Paris, Île-de-France Region, France
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France
APHP - Hôpital Bichât
Paris, Île-de-France Region, France
Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
Würzburg, Bavaria, Germany
Universitaetsklinikum Jena
Jena, Germany, Germany
Marienhaus Klinikum Mainz GmbH
Mainz, Germany, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse, Germany
Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Frankfurt am Main, Hesse, Germany
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, Hesse, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Dr. med. Jens Taggeselle
Markkleeberg, Saxony, Germany
General Hospital of Athens ''G. Gennimatas''
Athens, Attica, Greece
General Hospital of Athens ''Hippokratio''
Athens, Attica, Greece
General Hospital of Nea Ionia ''Konstantopouleio-Patision''
Athens, Attica, Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H
Chaïdári, Attica, Greece
General Hospital ''Asklepieio Voulas''
Voula, Attica, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
University General Hospital of Larissa
Larissa, Larissa, Greece
Papageorgiou General Hospital of Thessaloniki
Efkarpia, Thessaloniki, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece
ASST Spedali Civili di Brescia
Brescia, BS, Italy
Ospedale Infermi
Rimini, Emilia-Romagna, Italy
Ospedale di Arzignano
Arzignano, Lombardy, Italy
Centro Cardiologico Monzino
Milan, Lombardy, Italy
IRCCS Multimedica
Sesto San Giovanni, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, MI, Italy
A.O. Perugia - Ospedale S.Maria della Misericordia
Perugia, Province of Perugia, Italy
IRCCS San Raffaele
Roma, , Italy
Balsammedica Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
Lodz, , Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Szpital Sw. Anny w Miechowie
Miechów, , Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Poradnia AKA-MED Centrum Sp. z o.o.
Ruda Śląska, , Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera
Torun, , Poland
Hospital Universitario A Coruña
A Coruña, A Coruña, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital San Juan de la Cruz
Úbeda, Jaen, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Tarragona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, Spain
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Ulster Hospital
Dundonald, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Great Western Hospitals
Swindon, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-519219-32-00
Identifier Type: CTIS
Identifier Source: secondary_id
CY 1033
Identifier Type: -
Identifier Source: org_study_id