Safety Study of Finerenone with Standard Treatment for Heart Failure and Left Ventricular Systolic Dysfunction in Newborns, Children, and Young Adults up to 18 Years

What this Trial Is About

Researchers are studying finerenone, a drug under development, to treat newborns, children, and young adults with heart failure caused by left ventricular systolic dysfunction LVSD. LVSD weakens the left side of the heart, making it hard to pump blood properly, which can cause symptoms such as shortness of breath, tiredness, and poor growth. This Phase 3 study aims to evaluate the long-term safety and effects of finerenone when added to standard heart failure treatment in this young population, including those rolling over from a previous study and newly enrolled newborns under 6 months old. Participants will receive finerenone treatment for up to 9 months, alongside their usual heart failure care. The study will follow them for around 10 to 11 months, depending on their enrollment status. During this time, they will attend at least six visits where the study team will monitor vital signs, take blood samples, perform physical exams, and use heart imaging tests like electrocardiograms and echocardiography. Parents or guardians will also provide feedback on medication use and, for newborns and infants, on the drugs formulation acceptability. Throughout the study, researchers will track any medical problems that arise, changes in blood potassium levels, blood pressure, and kidney function. They will also measure heart function and levels of NT-proBNP, a marker related to heart failure. After finishing treatment, participants will have a follow-up health check one month later. This careful monitoring helps the team understand the safety and effects of finerenone in children and young adults with heart failure and LVSD.

A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction