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

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. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

Inclusion Criteria:Has a history of symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunctionHas biventricular physiology with a morphologic systemic left ventricleIs currently receiving stable medical therapy for HFHas left ventricular ejection fraction (LVEF) <45% assessed within 3 months before randomizationFemale 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 for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewedExclusion Criteria:Is clinically unstable-with at least one of the following: hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic or oral diuretic dose increaseHas a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulatorHas a history of single ventricle heart disease or has a morphologic systemic right ventricleHas 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 deviceHas sustained or symptomatic dysrhythmia uncontrolled with drug or device therapyHas had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformationsHas unoperated or residual hemodynamically significant congenital cardiac malformationsHas hypertrophic or restrictive cardiomyopathyHas active myocarditis or has been recently diagnosed with presumed or definitive myocarditisHas severe pulmonary hypertensionRequires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung diseaseHas severe chronic kidney diseaseHas hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class CHas a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medicationsHas concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator