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