Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2 / Phase 3

Age range

29 days - 17 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

342 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.
• Has biventricular physiology with a morphologic systemic left ventricle.
• Is currently receiving stable medical therapy for HF.
• Has left ventricular ejection fraction (LVEF) \<45% assessed within 3 months before randomization.
• Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate.
• Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.
• Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period

Exclusion Criteria:

• Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.
• Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.
• Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.
• Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.
• Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.
• Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.
• Has unoperated or residual hemodynamically significant congenital cardiac malformations.
• Has hypertrophic or restrictive cardiomyopathy.
• Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.
• Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.
• Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease
• Has severe pulmonary hypertension.
• Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease.
• Has severe chronic kidney disease.
• Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.
• Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.
• Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation
• Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.
• Has received a COVID-19 vaccination within 1 week before randomization.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (112)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

112 locations

Study team and timeline

Lead sponsor

Merck Sharp & Dohme LLC

Study start

May 31, 2023 Actual

Primary completion

Aug 20, 2029 Estimated

Study completion

May 12, 2032 Estimated

First posted

Feb 6, 2023 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts