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RECRUITINGPhase 3INTERVENTIONAL

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

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form - 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 Who Should NOT Join This Trial: Any of the following criteria will exclude potential patients from the study: - Have AFF on the screening ECG and are currently taking digoxin ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Omecamtiv Mecarbil (OM)

Oral Tablet

DRUG

Placebo

Oral Tablet

Locations (20)

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