Safe, long-term finerenone for children and young adults with heart failure and LV dysfunction

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

This phase 3 trial looks at long-term safety and potential benefit of finerenone added to standard heart failure treatment in pediatric and young adult patients with LVSD. It will collect data on adverse events and clinical outcomes to understand tolerability and how well the drug works over time. Eligible participants include infants under 6 months and other pediatric patients with LVSD, including those who previously participated in related trials. The study is sponsored by Bayer and conducted at several pediatric cardiology centers in the US.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE.
* For newly enrolled infants \<6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
* For newly enrolled infants \<6 months of age: Elevated NT-pro BNP levels (\> 500 ng/L) at screening.
* For newly enrolled infants \<6 months of age: Heart failure (HF) etiologies include 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 at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction.
* For newly enrolled infants \<6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).
* Newly enrolled newborns and infants \< 6 months of age must have a body weight of ≥3 kg at Visit 1.

Exclusion Criteria:

* For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \>5.5 mmol/L based on local laboratory results. After unblinding:

  * For participants who received finerenone in FIORE: K+ \>5.5 mmol/ L
  * For participants who received placebo in FIORE: K+ \>5.0 mmol/L for children ≥2 years of age, and \>5.3 mmol/L for children \<2 years of age (if eGFR is \<60 mL/min/1.73m² for participants \<2 years of age, the serum potassium threshold of \>5.0 mmol/L will be used for exclusion)
* For newly enrolled newborns and infants \< 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is \<60 mL/min/1.73m², the serum potassium threshold of \>5.0 mmol/L will be used for exclusion).
* For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² based on local laboratory results at FIORELLO Visit 1.
* For newly enrolled infants \< 6 months of age: Severe renal dysfunction with eGFR \< 30 ml/min/1.73m2 at screening or Visit 1.
* Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1.
* Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment.

Where it's running

• Cliniques Universitaires St-Luc (UCL) - Pediatric Cardiology
  Brussels, Brussels Capital, Belgium Recruiting
• Hospital Pequeno Principe
  Curitiba, Paraná, Brazil Recruiting
• Medical Center Nora- Heart ЕOOD Child Cardiology
  Sofia, Sofia City Province, Bulgaria Recruiting
• Nosokomeio Paidon I Agia Sofia, Cardiology Department
  Athens, Greece Recruiting
• Samsung Medical Center | Pediatric Cardiology
  Seoul, South Korea Recruiting
• Hospital Universitario La Paz | Cardiologia pediatrica
  Madrid, Madrid, Spain Recruiting

+82 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422937

Similar studies

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.