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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Left Ventricular Systolic Dysfunction

In brief

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.

Key facts

Study ID

NCT05714085

Run by

Merck Sharp & Dohme LLC

People needed

342

Starts

2023-05-31

Expected to finish

2032-04-15

Last updated by the study team

2026-07-13

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Lucile Packard Children's Hospital ( Site 0040) — Palo Alto, California, United States (enrolling)
• Loma Linda University Health System ( Site 0008) — San Bernardino, California, United States (enrolling)
• Children's Hospital Colorado ( Site 0012) — Aurora, Colorado, United States (enrolling)
• Children's National Medical Center ( Site 0020) — Washington D.C., District of Columbia, United States (enrolling)
• Johns Hopkins All Children's Hospital ( Site 0029) — St. Petersburg, Florida, United States (enrolling)
• Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001) — Atlanta, Georgia, United States (enrolling)
• Boston Children's Hospital ( Site 0035) — Boston, Massachusetts, United States (enrolling)
• C.S. Mott Children's Hospital ( Site 0033) — Ann Arbor, Michigan, United States (enrolling)
• Washington University-Pediatric Cardiology/ St. Louis Children's Hospital ( Site 0006) — St Louis, Missouri, United States (enrolling)
• Columbia University Medical Center-Pediatric Cardiology ( Site 0016) — New York, New York, United States (enrolling)
• The Children's Hospital at Montefiore ( Site 0030) — The Bronx, New York, United States (enrolling)
• Cincinnati Children's Hospital Medical Center ( Site 0034) — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022) — Cleveland, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia (CHOP) ( Site 0004) — Philadelphia, Pennsylvania, United States (enrolling)
• Children's Hospital of Pittsburgh ( Site 0010) — Pittsburgh, Pennsylvania, United States (enrolling)
• Le Bonheur Children's Hospital ( Site 0007) — Memphis, Tennessee, United States (enrolling)
• Children's Health-The Heart Center ( Site 0015) — Dallas, Texas, United States (enrolling)
• Texas Children's Hospital ( Site 0039) — Houston, Texas, United States (enrolling)
• Seattle Children's Hospital-Cardiology/Fetal Therapy ( Site 0019) — Seattle, Washington, United States (enrolling)
• Centre Hospitalier Régional de la Citadelle ( Site 0302) — Liège, Liege, Belgium (enrolling)
• UZ Gent ( Site 0301) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• UZ Leuven ( Site 0300) — Leuven, Vlaams-Brabant, Belgium (enrolling)
• Instituto Dante Pazzanese de Cardiology ( Site 0402) — São Paulo, São Paulo, Brazil (enrolling)
• Incor - Instituto do Coracao ( Site 0400) — São Paulo, Brazil (enrolling)
• The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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