A Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
The primary objective is to evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on the time to cardiovascular (CV) death or first heart failure (HF) event, whichever occurs first, in subjects with chronic HF with reduced ejection fraction (HFrEF) receiving standard of care (SoC) therapy.
The secondary objective is to evaluate the effects of OM on time to:
- CV death
- HF hospitalization
- All-cause death
To evaluate the effects of treatment with OM on change in patient-reported outcomes.
- History of chronic heart failure (HF) (defined as requiring treatment for HF for a minimum of 30 days before randomization)
- LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to screening
- NYHA class II to IV at most recent screening assessment
- Managed with HF standard of care therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
- Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF
- Elevated BNP or NT-proBNP