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A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
EU CTIS ID: 2022-500881-80-00
What this study is testing
To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 likely can't join if
- Has SBP <100 mm Hg or symptomatic hypotension.
- 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.
See the full eligibility 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.
- Has SBP <100 mm Hg or symptomatic hypotension.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Australia
- Mexico
- United States
- Argentina
- Hong Kong
- United Kingdom
- Malaysia
- Taiwan
- Ukraine
- Singapore
- Korea, Republic of
- Brazil
- Turkey
- Canada
- Guatemala
- Israel
- Colombia
- New Zealand
- Chile
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Australia; Mexico; United States; Argentina; Hong Kong and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.