Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

Last updated: April 3, 2025
Sponsor: Cytokinetics
Overall Status: Active - Recruiting

Phase

3

Condition

Congestive Heart Failure

Heart Failure

Hyponatremia

Treatment

Placebo

Omecamtiv Mecarbil (OM)

Clinical Study ID

NCT06736574
CY 1033
2024-519219-32-00
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 minimumof 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) ≥ 1000pg/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) ≥ 3000pg/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 priorto screening

  • Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg

Exclusion

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 acute coronary syndrome, cardiac surgery, valve surgery, any coronaryrevascularization, and/or cardiac resynchronization therapy within 3 months ofscreening

  • Are admitted to a long-term care facility or hospice

  • Have a projected survival of < 12 months due to non-cardiovascular causes based onclinical judgment

  • Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior toscreening

  • Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 daysprior to screening

  • Are receiving intravenous diuretics, intravenous vasodilators, or supplementaloxygen therapy ≤ 12 hours prior to screening

  • Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receivingdialysis at screening

  • Have previously had a solid organ transplant

  • Are receiving treatment in another investigational device or drug study or arewithin 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 tobreastfeed during treatment with IP or within 5 days after the end of treatment withIP

Study Design

Total Participants: 1800
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 19, 2024
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • Advanced Cardiovascular, LLC

    Alexander City, Alabama 35010
    United States

    Active - Recruiting

  • San Diego Cardiac Center

    San Diego, California 92123
    United States

    Active - Recruiting

  • CHF Heart Clinical (Subject Visits & IP Shipments)

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • South Florida Research Solutions, LLC

    Hollywood, Florida 33351
    United States

    Active - Recruiting

  • Broward Research Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Ocala Cardiovascular Research

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Cardiovascular Research of Northwest Indiana, LLC.

    Munster, Indiana 46321
    United States

    Active - Recruiting

  • Reid Physician Associates

    Richmond, Indiana 47374
    United States

    Active - Recruiting

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey 08807
    United States

    Active - Recruiting

  • Montefiore Medical Center (Moses Campus)

    Bronx, New York 10467
    United States

    Active - Recruiting

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

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • K&R Research LLC

    Marion, Ohio 43302
    United States

    Active - Recruiting

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

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

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee 37388
    United States

    Active - Recruiting

  • Medresearch Inc

    El Paso, Texas 79902
    United States

    Active - Recruiting

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