Actively Recruiting
Study to Investigate Finerenones Effects and Safety Compared to Placebo in Children Aged 6 Months to Under 18 Years With Heart Failure and Left Ventricular Systolic Dysfunction
Led by Bayer · Updated on 2026-05-18
111
Participants Needed
133
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating finerenone, a medicine that blocks a protein involved in heart and blood vessel damage, to see if it helps children with heart failure and left ventricular systolic dysfunction LVSD. Heart failure in children means the heart cannot pump enough blood, causing symptoms like tiredness, shortness of breath, and poor growth. This is the first study exploring finerenone specifically for this condition in children aged 6 months to less than 18 years. Participants will be randomly assigned to receive either finerenone or a placebo, which looks like the medicine but has no active drug, for about 3 months alongside their usual heart failure treatments. After this period, those who qualify can join an additional 9-month open-label phase where all will receive finerenone. During the study, children will visit the clinic at least three times for treatment and monitoring. Throughout the study, doctors will check vital signs, perform heart exams using ECG and echocardiogram, take blood samples, and ask about medicines and any health problems. Researchers will measure changes in a blood protein called NT-proBNP that indicates heart stress and monitor safety by tracking any side effects. Participants who do not join the extension phase will have a follow-up visit 30 days after their last treatment.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 6 months to less than 18 years old when informed consent/assent is signed
- Left ventricular systolic dysfunction with ejection fraction 50% or less at screening
- Elevated NT-proBNP levels: over 500 ng/l for children 6 months to under 2 years, over 300 ng/l for children 2 to under 18 years
- Heart failure causes including congenital heart defects, cardiomyopathy, myocarditis (at least 3 months old), neuromuscular or metabolic disorders, and others
- Receiving stable standard heart failure treatment for 30 days before randomization
- Body weight at least 4.0 kg at first visit
You will not qualify if you...
- High serum potassium levels: over 5.0 mmol/L for children 2 years and older, over 5.3 mmol/L for children 6 months to under 2 years (or over 5.0 mmol/L if kidney function is low)
- Severe kidney dysfunction with estimated glomerular filtration rate under 30 ml/min/1.73m²
- Systolic blood pressure below the 5th percentile for age, sex, and height
- Uncontrolled arrhythmias within 30 days before randomization
- Use of mineralocorticoid receptor antagonists within 30 days before randomization
- Need for intravenous vasoactive agents, mechanical ventilation, or circulatory support within 30 days before randomization
- Recent or planned heart surgery within 3 months before or after randomization
Research Team
B
Bayer Clinical Trials Contact
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