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Study on Anakinra for Treating Virus-Negative Myocarditis in Patients

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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 called virus-negative myocarditis. This condition involves inflammation of the heart muscle that is not caused by a virus. The study is testing a treatment that includes a medication called anakinra, which is an IL-1 inhibitor, meaning it helps reduce inflammation by blocking a specific protein in the body. The treatment will be given in addition to the standard care, which includes medications like azathioprine and prednisone, commonly used to suppress the immune system and reduce inflammation.

The purpose of the study is to evaluate the benefit of adding anakinra to the standard treatment for virus-negative myocarditis. Participants in the study will receive either anakinra or a placebo, along with the standard care. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving anakinra and who is receiving the placebo. This helps ensure that the results are not biased. The treatment will be administered through subcutaneous use, which means it is injected under the skin.

The study will last for a period of six months, during which the participants' heart function will be monitored. This will be done using a test called Trans Thoracic Echocardiography (TTE), which is a type of ultrasound that looks at how well the heart is pumping. The main goal is to see if the treatment can improve the heart's ability to pump blood, measured by something called the Left Ventricular Ejection Fraction (LVEF). The study aims to provide valuable information on whether anakinra can be a beneficial addition to the treatment of virus-negative myocarditis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will undergo initial assessments to confirm eligibility, including a heart imaging test called cardiac magnetic resonance and a biopsy to ensure virus-negative myocarditis.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups: one receiving the medication anakinra and the other receiving a placebo. This process is double-blind, meaning neither you nor the researchers will know which group you are in.

  3. Step 3

    Treatment phase

    If you are in the treatment group, you will receive anakinra through subcutaneous injection. This means the medication is injected under the skin.

    The dosage and frequency of anakinra will be determined by the study protocol, and you will also receive standard immunosuppressive therapy with medications called azathioprine and prednisone.

    The treatment phase will last for a specified duration, during which you will continue to receive these medications.

  4. Step 4

    Follow-up assessments

    Throughout the study, you will have regular follow-up assessments to monitor your heart function and overall health.

    These assessments will include tests like Trans Thoracic Echocardiography to evaluate your heart's ejection fraction, which measures how well your heart is pumping blood.

  5. Step 5

    End of study

    At the end of the study, you will have a final assessment to evaluate the effects of the treatment on your heart condition.

    The study aims to determine if anakinra combined with standard therapy improves heart function in patients with virus-negative myocarditis.

Who can join the trial?

4 criteria

  • Age between 18 and 75 years.
  • Diagnosis of myocarditis confirmed by a heart scan called cardiac magnetic resonance and a test showing no virus in the heart tissue.
  • Heart's left side pumping ability, known as left ventricular ejection fraction (LV-EF), is less than 55% as shown by an ultrasound of the heart.
  • Ability to understand and sign a document agreeing to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients with any other type of heart inflammation that is not proven to be virus-negative.
  • Patients who have not had an endomyocardial biopsy, which is a small tissue sample taken from the heart to check for inflammation.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not eligible for the specific group being studied.
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Investigated drugs

  • Anakinra

    is a medication used in this trial to help treat myocarditis, which is a condition where the heart muscle becomes inflamed. Anakinra works by blocking a specific protein in the body that can cause inflammation. By reducing inflammation, it may help improve heart function and reduce symptoms in patients with myocarditis.

  • Azathioprine

    is another medication used in the trial. It is an immunosuppressive drug, which means it helps to lower the activity of the body's immune system. In the context of myocarditis, azathioprine is used to prevent the immune system from attacking the heart muscle, which can help reduce inflammation and damage to the heart.

  • Prednisone

    is a type of steroid medication included in the trial. It is used to reduce inflammation in the body. For patients with myocarditis, prednisone can help decrease swelling and irritation in the heart muscle, which may lead to improved heart function and relief from symptoms.

What is already known about the treatment

Anakinra – Anakinra is administered as an injection under the skin and is currently being studied for its effectiveness in treating virus-negative myocarditis, a heart condition. It is an IL-1 inhibitor, meaning it works by blocking a specific protein in the body that can cause inflammation. This medication is being tested in combination with standard treatments like azathioprine and prednisone to see if it can provide additional benefits. Anakinra is classified as an immunosuppressive agent, which means it helps reduce the activity of the immune system to prevent inflammation.

Investigated diseases

Virus-negative myocarditis – Virus-negative myocarditis is a condition characterized by inflammation of the heart muscle, or myocardium, without the presence of a viral infection. This inflammation can lead to a reduction in the heart's ability to pump blood effectively, potentially causing symptoms such as fatigue, shortness of breath, and chest pain. The disease progresses as the inflammation persists, which can lead to further weakening of the heart muscle. Over time, this may result in the enlargement of the heart chambers and a decrease in the heart's pumping efficiency. The condition can vary in severity, with some individuals experiencing mild symptoms while others may have more significant cardiac dysfunction. The underlying cause of the inflammation in virus-negative myocarditis is often related to autoimmune or other non-infectious factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515472-13-00Estimated enrolment32 patientsSponsorOspedale San Raffaele S.r.l.

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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).