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 now · Phase 3

Conditions studied: Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)

In brief

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 dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth. The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively. The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD. To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR). In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study. The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \<6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have blood samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer * for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health a month after the participants take their last treatment.

Key facts

Study ID

NCT07192952

Run by

Bayer

People needed

117

Starts

2026-06-01

Expected to finish

2030-12-30

Last updated by the study team

2026-06-29

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Taichung Veterans General Hospital — Taichung, Taiwan (enrolling)
• UF Health Shands Hospital - Pediatric Cardiology — Gainesville, Florida, United States
• Nationwide Children's Hospital - Cardiology — Columbus, Ohio, United States
• Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta — Atlanta, Georgia, United States
• Riley Hospital For Children - Cardiology — Indianapolis, Indiana, United States
• Boston Children's Hospital - Main Campus - Cardiology — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital - Cardiology — Ann Arbor, Michigan, United States
• Children's Mercy Hospital Kansas City - Cardiology — Kansas City, Missouri, United States
• Washington University - St. Louis Children's Hospital - Cardiology — St Louis, Missouri, United States
• Icahn School of Medicine at Mount Sinai - Pediatric Cardiology — New York, New York, United States
• Columbia University Irving Medical Center - Pediatric Cardiology — New York, New York, United States
• The Children's Hospital at Montefiore - Cardiology — The Bronx, New York, United States
• Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension — Cincinnati, Ohio, United States
• Cleveland Clinic Children's — Cleveland, Ohio, United States
• Joe Dimaggio Children's Hospital - Cardiology — Hollywood, Florida, United States
• Children's Hospital of Philadelphia - Cardiology — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh - Cardiology — Pittsburgh, Pennsylvania, United States
• MUSC Shawn Jenkins Children's Hospital - Cardiology — North Charleston, South Carolina, United States
• Children's Medical Center Dallas - Cardiology — Dallas, Texas, United States
• Texas Children's Hospital - Cardiology — Houston, Texas, United States
• Eccles Primary Children's Outpatient Services - Cardiology — Salt Lake City, Utah, United States
• Hospital de Niños Sor María Ludovica — La Plata, Buenos Aires, Argentina
• Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina — Zárate, Buenos Aires, Argentina
• Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos — Rosario, Santa Fe Province, Argentina
• Nemours Children's Hospital - Delaware - Cardiology — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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