Vericiguat for Heart Failure

(VICTOR Trial)

Recruiting at 535 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Guideline-directed therapy

Disqualifiers: Amyloidosis, Sarcoidosis, Hypertrophic cardiomyopathy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

6105 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control during and for 1 month after the study.

I have chronic heart failure but haven't been hospitalized for it in the last 6 months.

I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.

Exclusion Criteria

I have been diagnosed with amyloidosis or sarcoidosis.

My blood pressure is below 100 mm Hg or I experience symptoms of low blood pressure.

Recent history (within the last year) of drug or alcohol abuse or dependence

Treatment Details

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.

Participant Groups

Group I: Vericiguat Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

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

Trials

4,096

Recruited

5,232,000+

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