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Study on the Effects and Safety of Finerenone for Patients with Heart Failure Who Cannot Use Steroidal Mineralocorticoid Receptor Antagonists

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What is this trial about?

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

This clinical trial is focused on studying a heart condition known as Heart Failure with reduced ejection fraction (HFrEF). This condition occurs when the heart muscle doesn't pump blood as well as it should. The study will evaluate a treatment using a medication called Finerenone, which is taken as a film-coated tablet. The medication is also referred to by its code name, BAY 94-8862. Participants in the study will either receive Finerenone or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to assess the effectiveness and safety of Finerenone in patients who cannot tolerate or are not eligible for treatment with other medications called steroidal mineralocorticoid receptor antagonists. These are typically used to treat heart failure but may not be suitable for everyone. The study will monitor participants over a period of time to see if Finerenone can help reduce the risk of cardiovascular death or heart failure events, which are serious complications of heart failure.

Participants will be randomly assigned to receive either Finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will track the time to the first occurrence of cardiovascular death or a heart failure event, as well as other outcomes like changes in symptoms and overall health status. The study is expected to continue until 2028, with recruitment starting in 2025.

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

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication finerenone, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    If you are assigned to the group receiving finerenone, you will take the medication in the form of a film-coated tablet. The medication is taken orally, meaning you will swallow the tablet with water. The dosage and frequency will be determined by the study team and provided to you at the start of the trial.

    If you are in the placebo group, you will take a tablet that looks the same as the finerenone tablet but does not contain the active ingredient. This is to ensure that the study results are not influenced by participants knowing which treatment they are receiving.

  3. Step 3

    Regular follow-up visits

    Throughout the study, you will have regular follow-up visits with the study team. These visits are important to monitor your health and the effects of the treatment. During these visits, you may undergo various tests and assessments to evaluate your heart condition and overall health.

    The study team will provide you with a schedule for these visits, and it is important to attend all of them to ensure the study's success and your safety.

  4. Step 4

    Completion of study

    The study is expected to continue until June 2028. At the end of the study, you will have a final visit with the study team. During this visit, your health will be assessed, and you will have the opportunity to discuss your experience in the study.

    The results of the study will be used to evaluate the effectiveness and safety of finerenone in patients with heart failure who are intolerant or not eligible for other treatments.

Who can join the trial?

8 criteria

  • Must be at least 18 years old or the legal age of adulthood in your country.
  • Have symptoms of HFrEF (Heart Failure with reduced Ejection Fraction), which means your heart doesn't pump blood as well as it should. You must have:
    • Symptoms that fit into NYHA class II – IV, which are categories used to describe how severe your heart failure symptoms are.
    • A recent heart test showing your heart's ejection fraction is less than 40%. This test could be an echocardiogram, cardiac MRI, or nuclear scan done within the last year.
    • A specific level of natriuretic peptide in your blood, which is a substance that can indicate heart failure. This level must be measured within 14 days if you were recently in the hospital for heart failure, or within 30 days if not.
    • Not currently taking sMRA (specific mineralocorticoid receptor antagonists like spironolactone, eplerenone, or canrenone/potassium canrenoate) because you either:
      • Had side effects like high potassium levels, worsening kidney function, sexual side effects, or low blood pressure that made you stop taking it.
      • Are considered ineligible for these medications by your doctor.
      • If you can have children, you must have a negative pregnancy test at the start and agree to use highly effective birth control during the study.
      • Must agree to participate by signing a consent form.

Who cannot join the trial?

1 criterion

  • Patients with a heart condition cannot participate in the study.
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Investigated drugs

Finerenone is a medication being studied for its potential benefits in people with heart failure who have a reduced ability of the heart to pump blood, a condition known as reduced ejection fraction. This medication is particularly for those who cannot take or do not tolerate other similar treatments called steroidal mineralocorticoid receptor antagonists. Finerenone works by blocking certain receptors in the body that can contribute to heart and kidney problems. The goal of using finerenone in this study is to see if it can help improve heart function and overall health in these patients, while also checking if it is safe and well-tolerated by them.

What is already known about the treatment

Finerenone – Finerenone is taken orally in the form of a tablet and is currently being studied for its effectiveness and safety in treating heart failure with reduced ejection fraction, especially in patients who cannot tolerate or are not eligible for traditional steroidal treatments. It is primarily used to manage heart conditions by blocking certain receptors in the body that can contribute to heart and kidney damage. At the molecular level, finerenone works by inhibiting the mineralocorticoid receptor, which helps reduce inflammation and fibrosis in the heart and kidneys. It is classified as a non-steroidal mineralocorticoid receptor antagonist.

Investigated diseases

Heart Failure with Reduced Ejection Fraction (HFrEF) – Heart Failure with Reduced Ejection Fraction is a condition where the heart muscle does not contract effectively, and less oxygen-rich blood is pumped out to the body. This condition often results from damage to the heart muscle, such as from a heart attack or long-term high blood pressure. Over time, the heart's ability to pump blood diminishes, leading to symptoms like shortness of breath, fatigue, and fluid retention. As the disease progresses, individuals may experience increased difficulty in performing physical activities. The heart's reduced pumping ability can lead to a buildup of fluid in the lungs and other parts of the body. This condition requires ongoing management to help maintain heart function and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508875-35-00Protocol code202304CPCEstimated enrolment2 676 patientsSponsorColorado Prevention Center

sourced from the EU Clinical Trials Register and site verification

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