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A study of finerenone added to standard treatment in children aged 6 months to under 18 years with heart failure and reduced left heart pumping function

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is looking at heart failure with left ventricular systolic dysfunction in children and teenagers. Heart failure is a condition where the heart cannot pump blood as well as it should, and left ventricular systolic dysfunction means that the left side of the heart, which is the main pumping chamber, is not working properly. The study will test a medication called finerenone, which is also known by its code name BAY 94-8862. Some participants will receive finerenone while others will receive placebo. All participants will continue to take their regular heart failure medicines that their doctors have prescribed. The medication being tested comes in different forms including tablets and granules that can be mixed with liquid for children who cannot swallow tablets.

The purpose of the study is to see if finerenone can reduce levels of a substance in the blood called NT-proBNP, which is a marker that shows how well the heart is working. The study will also look at how safe finerenone is and how the body processes the medication. Participants in this study will be children from 6 months old up to 18 years old who have heart failure caused by various conditions such as heart defects present from birth, inherited heart muscle problems, inflammation of the heart muscle, certain muscle disorders, or other causes affecting the heart's pumping ability. The children must already be taking standard medicines for heart failure for at least 30 days before joining the study.

During the study, participants will be assigned by chance to receive either finerenone or placebo in addition to their regular heart failure treatment. The treatment will last for 3 months, and doctors will measure various things including blood levels of NT-proBNP, potassium levels, blood pressure, kidney function, and heart function using ultrasound imaging of the heart. The study will also track any unwanted effects that occur and will monitor for serious heart-related events. Blood tests will be done to measure how much finerenone is in the body and how long it stays there. The entire study is expected to run from 2025 until the end of 2029.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    After joining the study, you will begin the treatment period. This study compares finerenone to placebo (a dummy medication with no active ingredient).

    You will be randomly assigned to receive either finerenone or placebo. This assignment is done by chance, like flipping a coin, and neither you nor your doctor will know which one you are receiving. This is called a double-blind study.

    The study medication will be given in addition to your current standard-of-care treatment for heart failure, which means you will continue taking your regular medications as prescribed by your doctor.

  2. Step 2

    Taking the study medication

    You will take the study medication by mouth (oral route). The medication comes in the form of film-coated tablets or granules for oral suspension, depending on what is suitable for you.

    Your doctor will determine the appropriate dose based on your age, weight, and medical condition.

    You must take the study medication regularly as instructed throughout the treatment period.

  3. Step 3

    Assessment at 3 months

    At 3 months after starting the study medication, your doctor will measure the levels of a substance called NT-proBNP in your blood. This substance is a marker that helps doctors understand how well your heart is working.

    This measurement will be compared to the level measured before you started the study medication to see if there has been any change.

  4. Step 4

    Regular monitoring visits

    Throughout the study, you will have regular visits where your doctor will monitor your health and safety.

    During these visits, your doctor will check for any side effects or unwanted reactions to the study medication. These are called treatment-emergent adverse events.

    Your doctor will measure your blood pressure, specifically the top number known as systolic blood pressure.

    Blood tests will be performed to check your potassium levels and kidney function.

    You will have echocardiography tests, which use sound waves to create pictures of your heart. These tests will show how well your heart is pumping and its size.

    Your doctor will also monitor for any serious heart-related events, such as worsening of heart failure symptoms.

  5. Step 5

    End of treatment

    At the end of treatment, your doctor will perform final assessments.

    These assessments will include measurements of potassium levels, blood pressure, kidney function, and heart function using echocardiography.

    All of these measurements will be compared to the ones taken before you started the study medication to evaluate any changes.

  6. Step 6

    Collection of blood samples for medication levels

    At certain times during the study, blood samples will be taken to measure how much finerenone is in your blood.

    These measurements help doctors understand how the medication moves into, through, and out of your body. This is called studying the pharmacokinetics of the medication.

    The measurements include the maximum concentration of finerenone in your blood and the total amount of the medication in your blood over time.

Who can join the trial?

6 criteria

  • The child must be between 6 months and less than 18 years old at the time of signing the consent form
  • The child must have reduced pumping function of the left side of the heart, which means the heart's ability to squeeze and pump blood is 50% or less as measured by an echocardiogram, which is an ultrasound test of the heart
  • The child must have elevated levels of NT-proBNP, which is a protein in the blood that indicates the heart is under stress. The required levels are: more than 500 ng/l for children 6 months to less than 2 years old, or more than 300 ng/l for children 2 years to less than 18 years old
  • The child must have heart failure caused by one of the following conditions: birth defects of the heart with two pumping chambers and the left side as the main pumping chamber, disease of the heart muscle without known cause, inherited or genetic heart muscle disease, past inflammation of the heart muscle that occurred at least 3 months before joining the study, muscle disorders such as Duchenne muscular dystrophy, metabolic disorders present from birth, mitochondrial disorders, damage from chemotherapy or infections or nutritional problems, damage from diseases like Kawasaki disease, or a condition where the left heart chamber has abnormal muscle structure
  • The child must be receiving standard treatment for heart failure as recommended by local guidelines or the doctor, and must have been on the same stable treatment plan for 30 days before joining the study
  • The child must weigh at least 4.0 kilograms at the first visit

Who cannot join the trial?

1 criterion

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

Finerenone is a medication being tested in this clinical trial for children and teenagers with heart failure and problems with how their heart pumps blood. This medicine is given in addition to the regular treatments that patients are already receiving for their heart condition. The study is looking at whether this medication can help improve certain markers in the blood that show how well the heart is working.

A placebo is also used in this study. A placebo looks like the real medication but contains no active medicine. It is used to compare the effects of the real medication against no treatment, which helps researchers understand if the medication is actually working.

What is already known about the treatment

Finerenone – Finerenone is a medication given by mouth in tablet form that is being studied for treating heart failure in children and teenagers aged 6 months to under 18 years who have weakened heart pumping function. It works by blocking certain proteins called mineralocorticoid receptors in the body, which helps reduce strain on the heart and decrease harmful processes that can damage heart tissue. This drug belongs to a class of medicines known as non-steroidal mineralocorticoid receptor antagonists and is currently being tested in clinical trials to see if it can lower levels of NT-proBNP, a substance in the blood that indicates heart stress, when added to standard heart failure treatments.

Investigated diseases

Heart Failure due to Systemic Left Ventricular Systolic Dysfunction – This is a condition where the heart's main pumping chamber, called the left ventricle, becomes weakened and cannot contract properly to pump blood throughout the body. When the left ventricle fails to squeeze effectively, it reduces the amount of oxygen-rich blood reaching the organs and tissues. This leads to fluid buildup in the lungs and other parts of the body, causing shortness of breath, fatigue, and swelling in the legs and ankles. The condition develops when the heart muscle is damaged by factors such as coronary artery disease, high blood pressure, or previous heart attacks. Over time, the weakened heart struggles more and more to meet the body's demands for blood and oxygen. As the disease progresses, symptoms typically worsen and daily activities become increasingly difficult to perform.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519829-38-00Protocol code21466Estimated enrolment111 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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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).