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A study of finerenone with standard treatment for children and young adults from birth to 18 years with heart failure and left ventricular systolic dysfunction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at heart failure with left ventricular systolic dysfunction in children and young people from birth to 18 years of age. Left ventricular systolic dysfunction means that the left lower chamber of the heart, which pumps blood to the body, does not squeeze or contract as well as it should. The treatment being studied is finerenone, also known as BAY 94-8862, which will be given in addition to standard of care treatment. Finerenone comes in different forms including film coated tablets and granules for oral suspension that are taken by mouth. The purpose of this study is to show that finerenone is safe when given for a long time together with standard treatment in children with this heart condition.

This study is an extension study, which means some participants may join after completing a previous study with finerenone, while other newly enrolled infants under 6 months of age can join directly if they meet certain health requirements. During the study, participants will receive finerenone along with their regular heart failure medications. The study will monitor various safety measures including blood potassium levels, blood pressure, and kidney function, as well as checking for any unwanted effects of the treatment. The study will also measure levels of a substance called NT-proBNP in the blood, which is a marker of heart function, and will use imaging with echocardiography to see how well the heart is working.

The study will last for approximately 270 days for each participant. Throughout this time, regular visits will be scheduled to check the safety and effects of the treatment. Blood samples will be collected to measure how much finerenone is in the body. For participants using the granules for oral suspension, there will be questions about the taste and texture of this form of the medicine. The study will track any side effects or health changes that occur during treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    Your participation in this study begins either after completing the previous FIORE study (21466) or as a newly enrolled infant under 6 months of age.

    If you are newly enrolled, your heart function will be assessed through an echocardiography (an ultrasound of the heart) to measure your left ventricular ejection fraction (a measurement showing how well the left side of your heart pumps blood).

    Blood tests will be performed to measure NT-pro BNP levels (a substance in the blood that indicates heart stress) and serum potassium levels (the amount of potassium in your blood).

    Your systolic blood pressure (the pressure in your arteries when your heart beats) will be measured.

    Your kidney function will be assessed by measuring estimated glomerular filtration rate (a calculation that shows how well your kidneys are filtering waste from your blood).

    If you are a newly enrolled newborn or infant under 6 months of age, your body weight must be at least 3 kilograms.

    You must have been receiving standard treatment for heart failure on a stable regimen for 30 days before this baseline visit.

  2. Step 2

    Treatment period with finerenone

    You will receive finerenone in addition to your standard heart failure treatment.

    The medication is available in different forms: film-coated tablets or granules for oral suspension (granules that can be mixed with liquid for swallowing).

    The medication is taken by mouth (oral use).

    The specific dosage, frequency, and exact duration of treatment will be determined based on your individual condition.

    You will continue taking finerenone for an extended period as part of this long-term safety study.

    Throughout the treatment period, you will attend regular visits for monitoring.

  3. Step 3

    Regular monitoring visits

    You will have scheduled visits throughout the study to monitor your safety and response to treatment.

    At each visit, your healthcare team will check for any adverse events (unwanted or harmful effects that may occur during treatment).

    Blood samples will be taken regularly to monitor your serum potassium levels and kidney function.

    Your blood pressure will be measured at each visit.

    Heart function assessments using echocardiography will be performed to evaluate changes in how your heart pumps blood.

    Blood tests will measure NT-proBNP levels to assess heart stress.

    At some visits, blood samples will be collected to measure the concentration of finerenone in your blood to understand how your body processes the medication.

    If you receive the pediatric formulation (granules for oral suspension), you may be asked to complete a questionnaire about the taste and texture of the medication.

  4. Step 4

    End of treatment visit

    The end of treatment visit will occur on Day 270, with a window of 7 days before or after (Visit 6).

    At this visit, comprehensive assessments will be performed including blood tests for potassium levels and kidney function.

    Your blood pressure will be measured.

    An echocardiography will be performed to evaluate your heart function.

    Blood tests will measure NT-proBNP levels.

    Any adverse events that occurred during the study will be documented.

    Changes in your condition from the beginning of the study to this final visit will be assessed.

Who can join the trial?

6 criteria

  • For participants continuing from a previous study: You must have taken part in the earlier finerenone research study called FIORE and completed it without stopping the treatment permanently before the final visit
  • For new participants under 6 months of age: Your baby must have left ventricular systolic dysfunction, which means the main pumping chamber on the left side of the heart is not squeezing properly, with a measurement called ejection fraction (the amount of blood pumped out with each heartbeat) of 50% or less
  • For new participants under 6 months of age: Your baby must have high levels of a substance called NT-pro BNP (greater than 500 mg/L) in the blood, which is a marker that shows the heart is under stress
  • For new participants under 6 months of age: The heart problem must be caused by one of these conditions: congenital heart defects (heart problems present at birth) with two working pumping chambers and the left side as the main pump; idiopathic cardiomyopathy (heart muscle disease with no known cause); inherited or genetic heart muscle disease; past myocarditis (heart muscle inflammation) that occurred at least 3 months before joining the study; neuromuscular disorder (conditions affecting nerves and muscles); inborn error of metabolism (genetic conditions affecting how the body processes nutrients); mitochondrial disorder (problems with the parts of cells that make energy); heart problems caused by chemotherapy, medical procedures, infection, rheumatic disease, or poor nutrition; heart problems caused by reduced blood flow such as Kawasaki disease or after heart surgery; or left ventricular noncompaction (a condition where the heart muscle does not develop normally)
  • For new participants under 6 months of age: Your baby must be receiving standard heart failure treatments according to local guidelines or as decided by the doctor, and must have been on a stable dose for 30 days before starting the study
  • New participants under 6 months of age must weigh at least 3 kilograms (about 6.6 pounds) at the first visit

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified in the available study information
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Investigated drugs

Finerenone is a medicine that will be tested in this study for children and teenagers with heart failure. It works by blocking certain hormones that can make heart problems worse. In this trial, finerenone will be given along with the regular treatments that patients are already taking for their heart condition. The purpose is to see if it is safe to use this medicine over a long period of time in young patients whose hearts are not pumping as well as they should.

What is already known about the treatment

Finerenone – Finerenone is a medication given by mouth in tablet form that is being studied as an addition to standard treatments for children and teenagers with heart failure caused by weakened pumping of the heart's main chamber. It works by blocking certain receptors in the body called mineralocorticoid receptors, which helps reduce inflammation and scarring in the heart and blood vessels. This medicine belongs to a class of drugs known as non-steroidal mineralocorticoid receptor antagonists and is currently approved for treating certain kidney and heart conditions in adults, while its safety and effectiveness in children with heart problems is being evaluated in ongoing clinical trials.

Investigated diseases

Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction – This condition occurs when the left ventricle of the heart loses its ability to contract effectively and pump blood throughout the body. The left ventricle is the heart's main pumping chamber, and when its systolic function is impaired, it cannot squeeze properly to push oxygen-rich blood to the rest of the body. As the condition progresses, the heart muscle becomes weaker and less efficient at pumping blood. This leads to blood backing up in the lungs and other parts of the body, causing fluid accumulation. Patients may experience increasing difficulty with physical activities as the heart struggles to meet the body's demands for oxygen and nutrients. Over time, the heart may enlarge as it tries to compensate for its reduced pumping ability.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519830-22-00Protocol code21467Estimated enrolment117 patientsSponsorBayer AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).