Heart Failure
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Heart Failure
1242-035 Enrolling

Chronic Heart Failure Research Trial (25 Months)


Treatment: Oral Age: 18 Years

Adults aged 18 years or older with chronic heart failure with reduced ejection fraction (HFrEF), may qualify to participate. Individuals must have a history of chronic heart failure on guideline-directed medical therapy (GDMT) with no events of heart failure hospitalization (HFH) within 6 months or outpatient IV diuretic use within 3 months, before randomization. Also, individuals must not be waiting for a heart transplant.

Participants will take investigational oral medication (active study drug) or placebo, once daily until the end of the treatment phase. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation will vary and may last about 25 months, involving at least 6 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: January 29, 2023

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

ClinicalTrials.gov ID

NCT05093933

Sponsor

Merck Sharp & Dohme LLC

Study Description

  • Brief 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.

  • Condition or Disease:

    Chronic Heart Failure With Reduced Ejection Fraction

  • Intervention/Treatment:

    Drug: Vericiguat
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Michael Hartleib

Cardiologist

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