Recruiting
Phase 3

Omecamtiv Mecarbil

Sponsor:

Cytokinetics

Code:

NCT06736574

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Omecamtiv Mecarbil (OM)

Placebo

Study Details

Brief summary:

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.

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

Study ID

NCT06736574

Start date

Dec 19, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

placebo comparator: 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.

Interventions

Omecamtiv Mecarbil (OM)

Oral Tablet

Placebo

Oral Tablet

Primary outcome measure

  • Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Cytokinetics MD

(650) 624-2929medicalaffairs@cytokinetics.com

Locations

Advanced Cardiovascular, LLC

Recruiting

Alexander City, Alabama, United States, 35010

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

UC San Diego Health - Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

Nutrition Research Center (SPH)

Recruiting

Loma Linda, California, United States, 92350

Keck Medical Center of USC (outpatient clinic)

Recruiting

Los Angeles, California, United States, 90033

UCLA Medical Center Cardiovascular Clinic

Recruiting

Los Angeles, California, United States, 90095

University of California, Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Sutter Institute for Medical Research (SIMR)

Recruiting

Sacramento, California, United States, 95816

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

San Diego Cardiac Center

Recruiting

San Diego, California, United States, 92123

California Pacific Medical Center Van Ness Campus

Recruiting

San Francisco, California, United States, 94109

Kaiser Permanente Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Stanford University Hospital / Stanford Health Care

Recruiting

Stanford, California, United States, 94303

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Cardiology Associates of Fairfield County, P.C

Recruiting

Bridgeport, Connecticut, United States, 06606

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Yale New Haven Health Heart & Vascular Center Outpatient Services

Recruiting

New Haven, Connecticut, United States, 06519

CHF Heart Clinical (Subject Visits & IP Shipments)

Recruiting

Clearwater, Florida, United States, 33756

Holy Cross Medical Group - Cardiology Associates

Recruiting

Fort Lauderdale, Florida, United States, 33308

South Florida Research Solutions, LLC

Recruiting

Hollywood, Florida, United States, 33351

UF Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Broward Research Center

Recruiting

Miami Beach, Florida, United States, 33140

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

AdventHealth

Recruiting

Orlando, Florida, United States, 32803

USF Health South Tampa Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33606

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Piedmont Atlanta Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Piedmont Fayette Hospital

Recruiting

Fayetteville, Georgia, United States, 30214

The Queen's Medical Center - Punchbowl

Recruiting

Honolulu, Hawaii, United States, 96813

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Cardiovascular Research of Northwest Indiana, LLC.

Recruiting

Munster, Indiana, United States, 46321

Deaconess Heart Group

Recruiting

Newburgh, Indiana, United States, 47630

Reid Physician Associates

Recruiting

Richmond, Indiana, United States, 47374

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

AHMG Cardiology and Surgery

Recruiting

Overland Park, Kansas, United States, 66211

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center

Recruiting

Bangor, Maine, United States, 04401

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Washington University Center for Advanced Medicine

Recruiting

St Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Advanced Heart Care, LLC

Recruiting

Bridgewater, New Jersey, United States, 08807

Monmouth Cardiology Associates, LLC

Recruiting

Eatontown, New Jersey, United States, 07724

Capital Cardiology Associates

Recruiting

Albany, New York, United States, 12205

Northwell Health North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Columbia University Medical Center / New York - Presbyterian

Recruiting

New York, New York, United States, 10032

Montefiore Medical Center (Moses Campus)

Recruiting

The Bronx, New York, United States, 10467

WakeMed Heart & Vascular - Cary Cardiology

Recruiting

Cary, North Carolina, United States, 27518

Clinical and Translational Research Center - University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-7064

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

Recruiting

Greensboro, North Carolina, United States, 27401

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

The Lindner Research Center at the Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Oklahoma State University Center for Health Sciences

Recruiting

Tulsa, Oklahoma, United States, 74127

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Capital Area Research, LLC

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Medical University of South Carolina - Gazes Research Institute

Recruiting

Charleston, South Carolina, United States, 29425

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

Recruiting

Rapid City, South Dakota, United States, 57701

Stern Cardiovascular Foundation, Inc.

Recruiting

Germantown, Tennessee, United States, 38138

Tennova Healthcare-Turkey Creek Medical Center

Recruiting

Knoxville, Tennessee, United States, 37934

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Tennessee Center for Clinical Trials

Recruiting

Tullahoma, Tennessee, United States, 37388

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

University of Texas Medical Branch - UTMB

Recruiting

Galveston, Texas, United States, 77555

CHI St. Luke's Health Baylor College of Medicine Medical Center

Recruiting

Houston, Texas, United States, 77030

Baylor Scott & White Medical Center- The Hearth Hospital

Recruiting

Plano, Texas, United States, 75093

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84132

Providence Advanced Heart Disease and Transplant

Recruiting

Spokane, Washington, United States, 99204

Medical College of Wisconsin / Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Mazankowski Alberta Heart Institute / University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G2B7

Kelowna General Hospital

Recruiting

Kelowna, British Columbia, Canada, V1Y1T2

SMH - Cardiology Clinical Trials Inc.

Recruiting

Surrey, British Columbia, Canada, V3V0C6

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Victoria Heart Institute Foundation

Recruiting

Victoria, British Columbia, Canada, V8R1B2

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H2A6

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Oakville Trafalgar Memorial Hospital - Halton Healthcare

Recruiting

Oakville, Ontario, Canada, L6M0L8

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N1J7

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

UHN-Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G2C4

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T1C8

CISSSL - Hopital Pierre-Le Gardeur

Recruiting

Terrebonne, Quebec, Canada, J6V 2H2

More Information

Sponsor

Cytokinetics

Last update posted

Aug 28, 2026

Last verified

Jul, 2026

Keywords

  • CK-1827452
  • omecamtiv mecarbil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cytokinetics on 2026-08-28.