This study is looking at heart failure with left ventricular systolic dysfunction in children and teenagers. Heart failure is a condition where the heart cannot pump blood as well as it should, and left ventricular systolic dysfunction means that the left side of the heart, which is the main pumping chamber, is not working properly. The study will test a medication called finerenone, which is also known by its code name BAY 94-8862. Some participants will receive finerenone while others will receive placebo. All participants will continue to take their regular heart failure medicines that their doctors have prescribed. The medication being tested comes in different forms including tablets and granules that can be mixed with liquid for children who cannot swallow tablets.
The purpose of the study is to see if finerenone can reduce levels of a substance in the blood called NT-proBNP, which is a marker that shows how well the heart is working. The study will also look at how safe finerenone is and how the body processes the medication. Participants in this study will be children from 6 months old up to 18 years old who have heart failure caused by various conditions such as heart defects present from birth, inherited heart muscle problems, inflammation of the heart muscle, certain muscle disorders, or other causes affecting the heart’s pumping ability. The children must already be taking standard medicines for heart failure for at least 30 days before joining the study.
During the study, participants will be assigned by chance to receive either finerenone or placebo in addition to their regular heart failure treatment. The treatment will last for 3 months, and doctors will measure various things including blood levels of NT-proBNP, potassium levels, blood pressure, kidney function, and heart function using ultrasound imaging of the heart. The study will also track any unwanted effects that occur and will monitor for serious heart-related events. Blood tests will be done to measure how much finerenone is in the body and how long it stays there. The entire study is expected to run from 2025 until the end of 2029.



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