A Phase 23 Study of Vericiguat to Treat Heart Failure in Children and Teens With Left Ventricular Systolic Dysfunction

What this Trial Is About

Researchers are investigating the effects of vericiguat compared to a placebo in children with heart failure caused by left ventricular systolic dysfunction. This study aims to see if vericiguat is better than a placebo at lowering levels of a heart failure marker called NT-proBNP over 16 weeks. The trial includes a base period and an optional extension period to further evaluate safety and long-term effects. During the base period, participants receive vericiguat orally once daily either as tablets in doses of 2.5 mg, 5 mg, or 10 mg, or as a suspension of 0.2 mgmL or 1 mgmL for up to 52 weeks. Another group receives a placebo in matching forms and schedules. After completing the base period, eligible participants may join the extension period, where they continue to receive vericiguat under similar dosing for additional monitoring. Participants will undergo regular assessments, including measuring NT-proBNP levels at baseline, Week 16, and Week 52 during the base period, as well as monitoring heart events and adverse effects. In the extension period, safety is tracked for up to 8 years, including adverse events and reasons for stopping the study drug. Pharmacokinetics of vericiguat are also studied through blood sampling at scheduled weeks. The total participation time may extend over several years for those in the extension phase.

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