Status:
NOT_YET_RECRUITING
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Lead Sponsor:
Bayer
Conditions:
Left Ventricular Systolic Dysfunction
Heart Failure (Pediatric)
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfu...
Eligibility Criteria
Inclusion
- 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 mg/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
- For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \>5.5 mmol/L. 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 at FIORE EoT or 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.
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT07192952
Start Date
April 1 2026
End Date
December 30 2030
Last Update
January 9 2026
Active Locations (131)
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1
Children's Hospital Colorado - Anschutz Medical Campus - Cardiology
Aurora, Colorado, United States, 80045
2
Nemours Children's Hospital - Delaware - Cardiology
Wilmington, Delaware, United States, 19803
3
UF Health Shands Hospital - Pediatric Cardiology
Gainesville, Florida, United States, 32608
4
Joe Dimaggio Children's Hospital - Cardiology
Hollywood, Florida, United States, 33021