This study looks at heart failure with left ventricular systolic dysfunction in children and young people from birth to 18 years of age. Left ventricular systolic dysfunction means that the left lower chamber of the heart, which pumps blood to the body, does not squeeze or contract as well as it should. The treatment being studied is finerenone, also known as BAY 94-8862, which will be given in addition to standard of care treatment. Finerenone comes in different forms including film coated tablets and granules for oral suspension that are taken by mouth. The purpose of this study is to show that finerenone is safe when given for a long time together with standard treatment in children with this heart condition.
This study is an extension study, which means some participants may join after completing a previous study with finerenone, while other newly enrolled infants under 6 months of age can join directly if they meet certain health requirements. During the study, participants will receive finerenone along with their regular heart failure medications. The study will monitor various safety measures including blood potassium levels, blood pressure, and kidney function, as well as checking for any unwanted effects of the treatment. The study will also measure levels of a substance called NT-proBNP in the blood, which is a marker of heart function, and will use imaging with echocardiography to see how well the heart is working.
The study will last for approximately 270 days for each participant. Throughout this time, regular visits will be scheduled to check the safety and effects of the treatment. Blood samples will be collected to measure how much finerenone is in the body. For participants using the granules for oral suspension, there will be questions about the taste and texture of this form of the medicine. The study will track any side effects or health changes that occur during treatment.



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