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Finerenone for Children with Heart Failure and LVSD

This study is looking for a better way to treat children aged 6 months to 17 years who have heart failure and left ventricular systolic dysfunction (LVSD). LVSD means the heart isn't pumping blood as well as it should. Researchers are testing a drug called finerenone (also known as Kerendia or BAY94-8862) against a placebo (an inactive substance) to see if it helps the heart. Finerenone works by blocking a protein that can cause inflammation and scarring in the heart. To join, children must have LVSD with a specific heart pumping ability (LVEF ≤ 50%) and elevated levels of a biomarker called NT-proBNP. The main goal is to see if finerenone improves NT-proBNP levels over about 90 days. The current status of this study is unclear, and it plans to enroll 111 participants.

Study design
This study is interventional and compares finerenone to a placebo. It plans to enroll 111 participants aged 6 months to 17 years.
What's involved
Participants will receive either finerenone or placebo for about 90 days. The study will measure changes in NT-proBNP levels from the start to the end of this period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 90±3, indicating follow-up for at least this duration.

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

NCT07188805

A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction

Recruiting
PHASE3Ages 6–17InterventionalTreatment
Bayer
~111 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Finerenone (Kerendia, BAY94-8862)Placebo

At a glance

Recruiting sites
20 of 133 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in NT-proBNP levels
Measured over From baseline to Day 90±3

Conditions

Left Ventricular Systolic Dysfunction
Heart Failure (Pediatric)

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NCT07188805

Where you'd take part

This study runs at 133 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

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, Turkey (Türkiye)no site contact published

    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

    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

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

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.

What this trial measures

  • Change in NT-proBNP levelsFrom baseline to Day 90±3