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Finerenone for Heart Failure in Children and Young Adults

This study is looking into how safe finerenone (Kerendia, BAY94-8862) is when taken for a longer time alongside standard treatments for children and young adults with heart failure and left ventricular systolic dysfunction (LVSD). LVSD means the left side of the heart is weak and struggles to pump blood effectively. Finerenone works by blocking a protein that causes inflammation and scarring in the heart, which may help the heart pump better. Researchers will measure side effects, changes in potassium levels, and changes in blood pressure to see how well finerenone works. The study is open to individuals from birth to 18 years old. Some participants will be joining from a previous finerenone study, while others will be newly enrolled infants under 6 months old with LVSD.

Study design
This is an interventional study planning to enroll 117 participants. It is testing finerenone in different doses.
What's involved
Participants will receive finerenone for about 270 days, with follow-up for 3 days after the last dose.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 days after their last dose of the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07192952

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

Recruiting
PHASE3Up to 18InterventionalTreatment
Bayer
~117 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Finerenone (Kerendia, BAY94-8862)

At a glance

Recruiting sites
1 of 132 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over From the start of study intervention to last study intervention (up to 277 days) + 3 days
+3 more outcomes measured

Conditions

Left Ventricular Systolic Dysfunction
Heart Failure (Pediatric)

Explore related trials

Heart FailureLeft Ventricular Systolic Dysfunction

NCT07192952

Where you'd take part

This study runs at 132 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Cadiologia pediatrica

    Torino, Italyno site contact published

    Not yet recruiting

  • Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility

    Liverpool, Merseyside, United Kingdomno site contact published

    Not yet recruiting

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, Turkey (Türkiye)no site contact published

    Not yet recruiting

  • ASST Grande Ospedale Metropolitano Niguarda - Struttura semplice dipartimentale cardiologia pediatrica

    Milan, Italyno site contact published

    Not yet recruiting

  • Athens General Children's Hospital Panagioti And Aglaia Kyriakou -2nd University Department of Pediatrics

    Athens, Greeceno site contact published

    Not yet recruiting

  • Athens General Children's Hospital Panagioti And Aglaia Kyriakou, Cardiology Department

    Athens, Greeceno site contact published

    Not yet recruiting

  • Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica

    Padova, Italyno site contact published

    Not yet recruiting

  • Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari

    Naples, Italyno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

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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.

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs)From the start of study intervention to last study intervention (up to 277 days) + 3 days

    TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms.

  • Change in serum potassium levelsFrom baseline to Day 270±7
  • Change in systolic blood pressure (SBP)From baseline to Day 270±7
  • Change in estimated glomerular filtration rate (eGFR)From baseline to Day 270±7