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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,800
Oral Tablet
Oral Tablet
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
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.
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
Time to the first event of CV death or HF event
Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event
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
Time to the first HF hospitalization
Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization
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
Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF
Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months
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
Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke
Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGPima Heart and Vascular Clinical Research
Tucson, Arizona, United States
WITHDRAWNNational Heart Institute
Beverly Hills, California, United States
RECRUITINGUC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
RECRUITINGNutrition Research Center (SPH)
Loma Linda, California, United States
RECRUITINGKeck Medical Center of USC (outpatient clinic)
Los Angeles, California, United States
RECRUITINGUCLA Medical Center Cardiovascular Clinic
Los Angeles, California, United States
RECRUITINGUniversity of California, Irvine Medical Center
Orange, California, United States
RECRUITINGSutter Institute for Medical Research (SIMR)
Sacramento, California, United States
RECRUITING...and 173 more locations
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
Time to CV death
Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality
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
Time to first event of stroke
Effect of omecamtiv mecarbil compared with placebo on risk of 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
Time to all-cause death
Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality
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