Jesus Del Monte

The trial investigates the safety, effectiveness, and how the body processes vericiguat in children with heart failure caused by left ventricular systolic dysfunction. It compares vericiguat to a placebo to see if vericiguat better reduces levels of a heart failure marker called NT-proBNP over 16 weeks. This is a combined Phase 2/3 study that includes a base period and an optional long-term extension period. Participants receive vericiguat either as tablets (2.5 mg, 5 mg, or 10 mg) or oral suspension (0.2 mg/mL or 1 mg/mL) once daily, or matching placebo tablets or suspension. After the initial 16-week base period, eligible participants can join an open-label extension lasting up to approximately 8 years, continuing to receive vericiguat to further evaluate safety and long-term effects. During the study, participants undergo tests to measure NT-proBNP at baseline and Week 16. In the extension, researchers monitor for any adverse events and reasons for stopping the study drug. Throughout, participants are assessed for heart function and safety, with follow-ups continuing for up to 8 years. This allows detailed evaluation of treatment impact and safety over both short and long terms.