Finerenone versus placebo added to usual care for children with heart failure and reduced left ventricular pumping

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 6 months to <18 years with left ventricular systolic dysfunction and elevated NT-proBNP are randomized to receive finerenone or matching placebo alongside standard heart-failure care. The trial measures changes in NT-proBNP levels, monitors safety and side effects, and collects pharmacokinetic data to understand how the drug moves through a child's body. Patients are followed over scheduled clinic visits and blood tests to track heart stress markers, clinical status, and adverse events. This is the first dedicated study of finerenone in a pediatric heart-failure population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed.
* Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
* Elevated NT-pro BNP levels

  * \>500 ng/l for children ≥ 6 months to \< 2 years of age
  * \>300 ng/l, for children ≥ 2 years to \<18 years
* Heart failure etiologies including congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure \[HF\]); LV noncompaction.
* Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization.
* Study participants must have a body weight ≥ 4.0 kg at Visit 1.

Exclusion Criteria:

* Serum/plasma potassium (based on local laboratory results):

  * \> 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 randomization visit based on local laboratory results.
* 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.

Where it's running

• Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
  Zárate, Buenos Aires, Argentina Recruiting
• Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
  Brussels, Belgium Recruiting
• Hospital Pequeno Principe
  Curitiba, Paraná, Brazil Recruiting
• Liga Alvaro Bahia Contra a Mortalidade Infantil - Hospital Martagão Gesteira
  Salvador, São Paulo, Brazil Recruiting
• Medical Center Nora- Heart ?OOD Child Cardiology
  Sofia, Sofia City Province, Bulgaria Recruiting
• Nosokomeio Paidon I Agia Sofia, Cardiology Department
  Athens, Athens, Greece Recruiting

+83 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.