Vericiguat for Heart Failure
(VICTOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests vericiguat, a medication, to determine if it can reduce the risk of heart-related deaths or hospital visits for individuals with chronic heart failure where the heart pumps less effectively. Participants will receive either vericiguat or a placebo (a non-active pill) to compare outcomes. The trial targets individuals with chronic heart failure with reduced ejection fraction who have not been recently hospitalized or required IV diuretics (medications that help remove excess fluid). Those managing heart failure without recent severe episodes might be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for heart failure.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it requires that you continue your guideline-directed medical therapy for heart failure. If you have recently changed or stopped any heart failure medications, you may not be eligible.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that vericiguat is safe for people with heart failure. Research indicates that 11.3% of patients taking vericiguat experienced low blood pressure with symptoms like dizziness, slightly higher than the 9.2% of patients who experienced it with a placebo.
Vericiguat is already approved for treating worsening heart failure, meaning its safety has been thoroughly checked and found acceptable for this condition. Evidence suggests that vericiguat is generally well-tolerated, with manageable side effects.12345Why do researchers think this study treatment might be promising for heart failure?
Vericiguat is unique because it specifically targets the heart's ability to relax and fill with blood by enhancing the soluble guanylate cyclase (sGC) pathway. Most treatments for heart failure, like ACE inhibitors, beta-blockers, and diuretics, focus on reducing symptoms like fluid retention or lowering blood pressure. Vericiguat, on the other hand, works by boosting a natural enzyme system that helps the heart pump more effectively, which might improve heart function and reduce hospitalizations. Researchers are excited because this novel mechanism could offer a new layer of benefit beyond what current medications provide, potentially improving outcomes for patients with chronic heart failure.
What evidence suggests that vericiguat might be an effective treatment for heart failure?
Research has shown that vericiguat, which participants in this trial may receive, can help individuals with heart failure with reduced ejection fraction (HFrEF). One study found that vericiguat lowered the risk of hospital visits for heart failure and death from heart-related issues compared to a placebo. Specifically, 35.5% of patients taking vericiguat experienced these events, while 38.5% of those on a placebo did. Another study reported fewer heart-related deaths with vericiguat (9.6%) compared to placebo (11.3%). These findings suggest that vericiguat could benefit people with chronic HFrEF.12467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with chronic heart failure who have a left ventricular ejection fraction of ≤40%, haven't been hospitalized for heart failure or needed IV diuretics recently, and are on stable heart failure medication. Women must not be pregnant, breastfeeding, or agree to use contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vericiguat or placebo, with doses titrated from 2.5 mg to 10 mg
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Vericiguat
Trial Overview
The study tests whether Vericiguat can reduce the risk of cardiovascular death or hospitalization due to heart failure compared to a placebo in patients with reduced ejection fraction (HFrEF). Participants will either receive Vericiguat or a placebo without knowing which one they're getting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily. The vericiguat dose will be titrated to 5 mg and to 10 mg.
Participants receive a starting matching placebo to vericiguat dose of 2.5 mg taken orally once daily. The matching placebo dose will be sham titrated to 5 mg and to 10 mg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Merck Provides New Results for VERQUVO® (vericiguat) ...
For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%) (HR 0.83; 95% CI ...
Vericiguat for patients with heart failure and reduced ...
Vericiguat reduced the risk of hospitalisation for heart failure and cardiovascular death in patients with HFrEF across a broad range of ...
Vericiguat Global Study in Subjects With Heart Failure With ...
The primary outcome, cardiovascular death or hospitalization for heart failure, occurred in 35.5% of the vericiguat group compared with 38.5% of ...
Effect of Vericiguat on Total Heart Failure Events in ...
Vericiguat resulted in lower cardiovascular (CV) and all-cause mortality compared with placebo in VICTOR, but there was not a statistically significant ...
Clinical Review - Vericiguat (Verquvo) - NCBI - NIH
The proportion of HHF as the first event was lower in the vericiguat group (27.4%) compared with the placebo group (29.6%), whereas proportion of CV death was ...
Blood pressure, safety and clinical efficacy of vericiguat in ...
Symptomatic hypotension occurred in 11.3% of vericiguat-treated patients compared with 9.2% of placebo-treated patients with an adjusted hazard ...
Vericiguat in Patients with Heart Failure and Reduced ...
Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 ...
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