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 (VICTOR)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2025
  • participants needed
    6000
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 29 October 2022
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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.

Details
Condition Chronic Heart Failure With Reduced Ejection Fraction
Treatment Placebo, Vericiguat
Clinical Study IdentifierNCT05093933
SponsorMerck Sharp & Dohme LLC
Last Modified on29 October 2022

Eligibility

 Yes No Not Sure

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
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
Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels

Exclusion Criteria

Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device
Has SBP <100 mm Hg or symptomatic hypotension
Amyloidosis or sarcoidosis
Hypertrophic cardiomyopathy
Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization
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
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