ClinicaliQ Trial Snapshot
- 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….
- What is being tested: Finerenone (a non-steroidal mineralocorticoid receptor antagonist) efficacy, safety, and pharmacokinetics in children with heart failure and left ventricular systolic dysfunction, when added to standard heart failure therapy compared to placebo.
- Patient eligibility overview: Children diagnosed with heart failure and left ventricular systolic dysfunction who are already receiving standard treatment, meeting specific age and clinical criteria for enrolment.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children. The study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This…
Eligibility Snapshot
- : * Participants must be 6 months to 500 ng/l for children ≥ 6 months to < 2 years of age * >300 ng/l, for children ≥ 2 years to 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit * > 5.3 mmol/L for children ≥ 6 months to < 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m², threshold of > 5.0 mmol/L will be used) * Severe renal dysfunction with eGFR < 30 ml/min/1.73m² at screening or randomization visit. * Systolic blood pressure (SBP) < 5th percentile for age, sex and height at screening or randomization. * Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization. * Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization. * Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization. * Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.