Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction
Why the study?
Prior attempts at increasing cardiac contractility with oral drugs in HFrEF uniformly increased mortality, leaving it unknown whether selective cardiac myosin activation with omecamtiv mecarbil can safely improve clinical outcomes.
Does omecamtiv mecarbil reduce the time to cardiovascular death or first heart failure event in patients with chronic symptomatic heart failure with reduced ejection fraction?
Population
More than 8,000 patients with chronic symptomatic HFrEF (LVEF ≤35%) and elevated natriuretic peptides
Comparison
Pharmacokinetic-guided omecamtiv mecarbil (25, 37.5, or 50 mg twice daily) vs oral placebo
Design
International, multicenter, randomized, double-blind, placebo-controlled, event-driven trial
Authors
Discussion
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Member takes
Implication
May reduce CV events in symptomatic HFrEF; leaves open durability of benefit and mortality effects.
Structured PICO
Does omecamtiv mecarbil reduce the time to cardiovascular death or first heart failure event in patients with chronic symptomatic heart failure with reduced ejection fraction?
P
Population
More than 8,000 patients with chronic symptomatic (New York Heart Association functional class II to IV) heart failure, left ventricular ejection fraction ≤35%, elevated natriuretic peptides, and either current hospitalization for HF or history of hospitalization or emergency department visit for HF within a year of screening.
I
Intervention
Oral omecamtiv mecarbil employing a pharmacokinetic-guided dose titration strategy using doses of 25, 37.5, or 50 mg twice daily.
C
Comparator
Oral placebo.
O
Outcome
Time to cardiovascular death or first HF event.composite
Cite This Study
Teerlink et al. (2020) studied this question.