A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Heart Failure With Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT05093933

Run by

Merck Sharp & Dohme LLC

People needed

6106

Starts

2021-11-02

Expected to finish

2025-02-05

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of chronic HF [New York Heart Association (NYHA) Class II to IV] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
• Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
• Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.

You may not qualify if…

• Has SBP <100 mm Hg or symptomatic hypotension.
• Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
• Amyloidosis or sarcoidosis.
• Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
• Hypertrophic cardiomyopathy.
• Acute myocarditis or Takotsubo cardiomyopathy.
• History of heart transplant.
• Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
• Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
• History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
• Malignancy or other noncardiac condition limiting life expectancy to <3 years.
• Requires continuous home oxygen for severe pulmonary disease.
• Interstitial lung disease.
• Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
• Recent history (within the last year) of drug or alcohol abuse or dependence.

Where it is running

• University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153) — Birmingham, Alabama, United States
• Heart Center Research, LLC ( Site 0156) — Huntsville, Alabama, United States
• Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075) — Gilbert, Arizona, United States
• Valley Clinical Trials, Inc. ( Site 0085) — Covina, California, United States
• VA West Los Angeles Medical Center-Cardiology ( Site 0149) — Los Angeles, California, United States
• Valley Clinical Trials Inc ( Site 0006) — Northridge, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010) — Torrance, California, United States
• Blue Coast Research Center ( Site 0053) — Vista, California, United States
• Excel Medical Clinical Trials ( Site 0008) — Boca Raton, Florida, United States
• Universal Axon Clinical Research, LLC ( Site 0022) — Doral, Florida, United States
• Holy Cross Hospital ( Site 0100) — Fort Lauderdale, Florida, United States
• Indago Research and Health Center Inc ( Site 0011) — Hialeah, Florida, United States
• South Florida Research Solutions ( Site 0058) — Hollywood, Florida, United States
• University of Florida - Jacksonville ( Site 0169) — Jacksonville, Florida, United States
• East Coast Institute for Research, LLC ( Site 0047) — Jacksonville, Florida, United States
• Cardiovascular Research Center of South Florida ( Site 0074) — Miami, Florida, United States
• ProLive Medical Research ( Site 0032) — Miami, Florida, United States
• Peace River Cardiovascular Center ( Site 0088) — Port Charlotte, Florida, United States
• BAYCARE MEDICAL GROUP ( Site 0099) — Safety Harbor, Florida, United States
• East Coast Institute for Research - St. Augustine ( Site 0016) — Saint Augustine, Florida, United States
• Cardiovascular Center of Sarasota ( Site 0154) — Sarasota, Florida, United States
• Emory University School of Medicine ( Site 0123) — Atlanta, Georgia, United States
• IACT Health ( Site 0106) — Columbus, Georgia, United States
• NSC Research ( Site 0068) — Johns Creek, Georgia, United States
• Advanced Cardiovascular - Alexander City ( Site 0038) — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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