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

This study is open to children between 6 months and 17 years of age who have heart failure where their heart's main pumping chamber isn't working as well as it should. They must also have elevated levels of a specific protein in their blood that indicates heart stress. Children will already be receiving their usual heart failure medications and these treatments should have been stable for at least a month before joining the study. They also need to weigh at least 4 kilograms (about 9 pounds).

There are some reasons why a child might not be able to join the study. These include having very high levels of potassium in their blood, which can be a concern with this type of medicine, or very poor kidney function. Children with very low blood pressure or certain uncontrolled fast or irregular heartbeats would also not be able to participate. Also, if a child has recently taken a similar type of heart medicine (called a mineralocorticoid receptor antagonist) in the last month, they wouldn't be eligible.

If your child qualifies for the study, they will be given either finerenone or a dummy medicine (placebo) for three months, while continuing their usual heart failure treatments. Which group your child is in will be decided by chance, like flipping a coin.

During these three months, your child will need to visit the study clinic at least three times. At these visits, doctors and nurses will take their blood pressure, heart rate, temperature, and measure their height and weight. They will also perform heart checks with an ECG (which records the heart's electrical activity) and an echocardiogram (an ultrasound scan of the heart). Blood samples will be taken, and your child will have a general health check-up. You or your child will be asked about any medicines they are taking and if they have experienced any new medical problems or side effects.

After the first three months, if your child is still eligible, there's an option to join a longer study for another nine months. In this part, all children will receive finerenone. If you decide not to join the longer study, your child will have one final check-up about a month after their last study medicine dose.