Vericiguat Outcomes Study in HFrEF
Research type
Research Study
Full title
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
IRAS ID
1004096
Contact name
Vivienne Liddle
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-005941-18
Clinicaltrials.gov Identifier
Research summary
Heart failure is a leading cause of cardiovascular heart disease (condition affecting the heart or blood vessels) and death and constitutes a major public health problem worldwide. Despite treatment with guideline-directed medical therapy for heart failure (GDMT), patients with chronic heart failure with reduced ejection fraction (HFrEF) remain at high risk. Clinical outcomes for patients with chronic heart failure remain poor. Therefore, drugs are needed that effectively target disease mechanisms not addressed by current standard therapy.
The trial drug, vericiguat (MK-1242) works by targeting dysfunction to improve regulation of heart muscle tone and heart function. Vericiguat (MK-1242), is approved in the USA in high-risk patients to reduce the risk of cardiovascular death and heart failure hospitalisation.
In another clinical trial (VICTORIA), it was shown that vericiguat reduces the risk of cardiovascular death and heart failure hospitalisation in a well-treated, but very high-risk population of adults with chronic HFrEF who have experienced a recent worsening heart failure event.
This trial will evaluate the effectiveness of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalisation in people with stable chronic heart failure on a background of standard of care. Approximately 6000 participants will be randomised and enrolled into the trial. Participants will be randomised into a 1:1 ratio, either receiving vericiguat or a placebo, at starting dose of 2.5mg, then increased to 5mg up to the target dose of 10mg. Participants will be in the trial for approximately 2 – 3.5 years and this time includes a Screening Phase, Treatment Phase and Follow up Phase.The trial is funded by Merck Sharp & Dohme Corp., and will take place at 15 trial centres in the UK.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0649
Date of REC Opinion
27 Oct 2021
REC opinion
Further Information Favourable Opinion