Heart FailureHeart Failure With Reduced Ejection Fraction
Investigational drug(s) / intervention(s)
Omecamtiv Mecarbil (OM)Placebo
Omecamtiv Mecarbil (OM): Oral Tablet
Placebo: Oral Tablet
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
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or 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 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.
Trial sites (205)
Facility
City
Region
Status
Advanced Cardiovascular, LLC
Alexander City
Alabama
Recruiting
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Pima Heart and Vascular Clinical Research
Tucson
Arizona
Withdrawn
National Heart Institute
Beverly Hills
California
Recruiting
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla
California
Recruiting
Nutrition Research Center (SPH)
Loma Linda
California
Recruiting
Keck Medical Center of USC (outpatient clinic)
Los Angeles
California
Recruiting
UCLA Medical Center Cardiovascular Clinic
Los Angeles
California
Recruiting
University of California, Irvine Medical Center
Orange
California
Recruiting
Sutter Institute for Medical Research (SIMR)
Sacramento
California
Recruiting
UC Davis Health
Sacramento
California
Recruiting
San Diego Cardiac Center
San Diego
California
Recruiting
California Pacific Medical Center Van Ness Campus
San Francisco
California
Recruiting
Kaiser Permanente Santa Clara
Santa Clara
California
Recruiting
Stanford University Hospital / Stanford Health Care
Stanford
California
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance
California
Recruiting
Rocky Mountain Regional VA Medical Center
Aurora
Colorado
Recruiting
Cardiology Associates of Fairfield County, P.C
Bridgeport
Connecticut
Recruiting
Hartford Hospital
Hartford
Connecticut
Recruiting
Yale New Haven Health Heart & Vascular Center Outpatient Services
New Haven
Connecticut
Recruiting
CHF Heart Clinical (Subject Visits & IP Shipments)
Clearwater
Florida
Recruiting
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale
Florida
Recruiting
South Florida Research Solutions, LLC
Hollywood
Florida
Recruiting
UF Health Jacksonville
Jacksonville
Florida
Recruiting
Broward Research Center
Miami Beach
Florida
Recruiting
Ocala Cardiovascular Research
Ocala
Florida
Recruiting
AdventHealth
Orlando
Florida
Recruiting
USF Health South Tampa Center for Advanced Healthcare
Tampa
Florida
Recruiting
Grady Health System
Atlanta
Georgia
Recruiting
Piedmont Atlanta Hospital
Atlanta
Georgia
Recruiting
Emory Clinic
Atlanta
Georgia
Recruiting
Piedmont Fayette Hospital
Fayetteville
Georgia
Recruiting
The Queen's Medical Center - Punchbowl
Honolulu
Hawaii
Recruiting
Midwest Cardiovascular Institute
Naperville
Illinois
Recruiting
Cardiovascular Research of Northwest Indiana, LLC.
Munster
Indiana
Recruiting
Deaconess Heart Group
Newburgh
Indiana
Recruiting
Reid Physician Associates
Richmond
Indiana
Recruiting
The University of Kansas Medical Center
Kansas City
Kansas
Recruiting
AHMG Cardiology and Surgery
Overland Park
Kansas
Recruiting
University Medical Center New Orleans
New Orleans
Louisiana
Recruiting
+ 165 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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