Patients assigned to the treatment, omecamtiv mecarbil, experienced a statistically significant difference in a composite endpoint of time to cardiovascular death or time to first heart failure event.
Late-breaking clinical trial results from GALACTIC-HF provide new insight into how best to treat patients with heart failure with reduced ejection fraction (HFrEF).
The trial, which was investigating the effectiveness of omecamtiv mecarbil, an investigational drug designed to directly target the contractile mechanisms of the heart, met its primary endpoint, a composite of time to cardiovascular death and time to first heart failure event, such as hospitalization. Findings were presented Friday by John Teerlink, MD, of University of California, San Francisco, at the virtual American Heart Association Scientific Sessions 2020 and published simultaneously in the New England Journal of Medicine.
DCRI’s Michael Felker, MD, was a member of the study executive committee, and DCRI’s Clinical Events Classification (CEC) group oversaw event adjudication, with the CEC co-chaired by Felker and DCRI’s Renato Lopes, MD, PhD, faculty director for DCRI CEC.
GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes studies in heart failure conducted to date, randomized over 8,000 patients from 35 countries to either omecamtiv mecarbil or placebo.
In addition to the primary composite endpoint, the trial was examining the secondary endpoints of time to cardiovascular death, patient-reported outcomes, time to first heart failure hospitalization, and time to all-cause death. The trial did not find a statistically significant difference in the secondary endpoints.
“GALACTIC-HF was the first trial to examine whether selectively increasing cardiac contractility in patients with heart failure and reduced ejection fraction through this novel mechanism of action would result in improved clinical outcomes,” Felker said. “Ongoing analysis of GALACTIC-HF will provide new insights into the potential role of this agent in treating patients with heart failure.”
“For this study, the DCRI’s Clinical Events Classification group reviewed and adjudicated over 11,000 clinical events,” Lopes said. “It is nice to see all this work being translated to another treatment option that can help in improving outcomes in patients with heart failure and reduced ejection fraction. Studies like this are helping to transform the treatment of patients with heart failure.”