Study Launched Evaluating Vericiguat in Certain Patients With Chronic Heart Failure
Merck has launched the VICTOR study, a phase 3 randomized, placebo-controlled cardiovascular clinical trial of vericiguat (Verquvo) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. The study is planned to enroll approximately 6000 adults with chronic heart failure and reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient intravenous (IV) diuretic use within 3 months prior to randomization.
Officials with the FDA previously approved vericiguat to reduce risk of cardiovascular death and hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. This approval in January 2021 was based on the VICTORIA study.
“The VICTOR study will assess initiating vericiguat earlier in the heart failure journeys of certain patients,” said Javed Butler, MD, MPH, MBA, the Patrick H. Lehan Chair in Cardiovascular Research, and professor and chairman of the department of medicine at the University of Mississippi Medical Center, in a press release.
The VICTOR trial is anticipated to take 39 months to complete, and the investigators emphasize that efforts are being made to ensure that the patient population studied in the trial represents the diverse nature of people who may be diagnosed with chronic heart failure and reduced ejection fraction of less than 40% who have not had a recent worsening heart failure event. The trial is planned to include patients from 34 countries at approximately 500 sites around the world.
“The initiation of the phase 3 VICTOR study reflects our commitment to finding additional options for a chronic heart failure condition that affects more than 3 million people in the US each year,” said Joerg Koglin, MD, PhD, vice president of Global Clinical Development and therapeutic area head, Cardiovascular for Merck Research Laboratories, in the release. “Along with our partners at Bayer, we look forward to studying vericiguat in a more stable chronic heart failure population than was studied in the phase 3 VICTORIA study.”
Merck announces initiation of phase 3 study evaluating VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction who have not had a recent worsening heart failure event [news release]. Merck; November 11, 2021. Accessed November 11, 2021. https://www.merck.com/news/merck-announces-initiation-of-phase-3-study-evaluating-verquvo-vericiguat-in-patients-with-chronic-heart-failure-and-reduced-ejection-fraction-who-have-not-had-a-recent-worsening-heart-failure/