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

Purpose

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.

Condition

  • Chronic Heart Failure With Reduced Ejection Fraction

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Vericiguat 		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.
  • Drug: Vericiguat
    2.5, 5.0, or 10.0 mg orally once daily
    Other names:
    • MK-1242
    • BAY 1021189
Placebo Comparator
Placebo 		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.
  • Drug: Placebo
    0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact