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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Investigate the Efficacy, Safety, and PK/ PD of Finerenone, in Addition to Standard-of-care, in Pediatric Patients, 6 Months to < 18 Years of Age With Heart Failure (HF) and Left Ventricular Systolic Dysfunction (LVSD)

Phase 3 Interventional Bayer · NCT07188805

This will test whether finerenone, given with standard heart-failure treatment, helps children aged 6 months to under 18 with reduced left ventricular function compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment111 (estimated)
Ages6 Months to 17 Years
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionschemotherapy
Locations133 sites (Aurora, Colorado and 132 other locations)
Trial IDNCT07188805 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children 6 months to under 18 with left ventricular ejection fraction ≤50% and elevated NT-proBNP who are receiving standard heart-failure therapy.

Not a fit: Children without reduced left ventricular function, with normal NT-proBNP, or with medical conditions that make finerenone unsafe may not receive benefit from this treatment.

Why it matters

Potential benefit: If successful, finerenone could reduce heart stress and improve heart function and symptoms in children with left ventricular systolic dysfunction.

How similar studies have performed: Nonsteroidal and steroidal mineralocorticoid receptor antagonists have shown benefit in adults with heart failure and related conditions, but this is the first pediatric trial specifically testing finerenone for childhood LV systolic dysfunction.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 potassium:

  * \> 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.

Where this trial is running

Aurora, Colorado and 132 other locations

+83 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Left Ventricular Systolic DysfunctionHeart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.