Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Chronic Heart Failure With Reduced Ejection Fraction, Heart Failure, Vericiguat

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010)
    Torrance California 90502 United States
  • Valley Clinical Trials Inc ( Site 0006)
    Northridge California 91325 United States
  • VA West Los Angeles Medical Center-Cardiology ( Site 0149)
    Los Angeles California 90073 United States
  • Blue Coast Research Center ( Site 0053)
    Vista California 92081 United States
  • Valley Clinical Trials, Inc. ( Site 0085)
    Covina California 91723 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT05093933
Phase
Phase 3 Heart Failure Research Study
Study Type
Interventional
Participants
Expecting 6000 study participants
Last Updated