Study of Finerenone Added to Standard Treatment for Children 6 Months to Under 18 Years With Heart Failure and Left Ventricular Systolic Dysfunction

What this Trial Is About

Researchers are investigating a new treatment for children with heart failure and left ventricular systolic dysfunction LVSD, a condition where the heart cannot pump enough blood. This study aims to find out if finerenone, a drug that blocks a protein involved in heart and blood vessel damage, can help improve heart function compared to a placebo. This is the first study to test finerenone specifically in children with these heart problems. Participants aged 6 months to less than 18 years with heart failure and LVSD will be randomly assigned to receive either finerenone or a placebo for about 3 months, while continuing their usual heart failure care. After this period, those who qualify can join a 9-month open-label extension where everyone receives finerenone. Participants not joining the extension will have a follow-up visit 30 days after their last treatment. During the study, children will visit the study site at least three times for physical exams, heart tests like ECG and echocardiogram, blood pressure and vital sign checks, blood samples, and medication and side effect reviews. Researchers will measure changes in NT-proBNP, a protein indicating heart stress, and monitor safety through tracking adverse events and other heart and kidney function tests. The total participation can last up to approximately one year including the extension phase.

A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction