Patients with heart failure and a reduced ejection fraction who received the selective cardiac myosin activator omecamtiv mecarbil had a lower risk of a composite of heart failure events and cardiovascular death than those who received placebo, according to results from the GALACTIC-HF trial presented Nov. 13 during AHA 2020 and simultaneously published in the New England Journal of Medicine.

Researchers randomly assigned 8,256 patients with chronic heart failure and reduced ejection fraction (35% or less) to receive omecamtiv mecarbil (25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart failure therapy. The primary outcome was a composite of a first heart failure event or cardiovascular-related death.

Of note, participants were predominantly male (79%) and white (78%), with an average age of 66 years and average ejection fraction of 27%. In addition, 62% had coronary artery disease; 40% had Type 2 diabetes; 70% had high blood pressure; 36% had chronic kidney disease; and 25% were hospitalized at the time of enrollment. While only 7% of participants self-reported as Black, more Black patients were enrolled in GALACTIC-HF than in any contemporary, international heart failure trial.

Over a median of 21.8 months, a primary-outcome event occurred in 1,523 of 4,120 patients (37.0%) in the omecamtiv mecarbil group compared with 1,607 of 4,112 patients (39.1%) in the placebo group (p=0.03). A total of 808 patients (19.6%) in the omecamtiv mecarbil group died from cardiovascular-related causes compared with 798 patients (19.4%) in the placebo group. Researchers observed no significant difference between the two groups in secondary outcomes, including change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptoms score or frequency of cardiac ischemic and ventricular arrhythmia events.

“These findings support the hypothesis that improving cardiac function by selectively targeting the cardiac sarcomere with omecamtiv mecarbil can improve clinical outcomes,” said John R. Teerlink, MD, FACC, and colleagues. However, they noted the “lack of effect on death from either cardiovascular causes or any cause is surprising, given the prior evidence with omecamtiv mecarbil of improvements in left ventricular volumes and function, as well as decreases in heart rate and NT-proBNP.”

Looking ahead, Teerlink said “the findings will inform potential future implementation of omecamtiv mecarbil to treat chronic heart failure.”

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: AHA Annual Scientific Sessions, AHA20, Stroke Volume, Heart Failure, Ventricular Dysfunction, Left

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