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

COMPLETEDPHASE3

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

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

NCT05093933•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.
+5 more criteria

Locations (519)

Advanced Cardiovascular - Alexander City ( Site 0038)

Alexander City, Alabama, United States

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

Key Dates

Start Date

November 2, 2021

Primary Completion Date

November 20, 2024

Completion Date

February 5, 2025

Last Updated

December 19, 2025

Enrollment

6,106

ACTUAL participants

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Interventions

Vericiguat

DRUG

Placebo

DRUG

An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions

NCT06632483

Chronic Heart Failure With Reduced Ejection FractionWorsening Chronic Heart Failure

View study

COMPLETED

An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan

NCT06697353

Chronic Heart FailureChronic Heart Failure With Reduced Ejection Fraction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions

An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan

An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States

Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.