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Study of Anakinra compared to placebo for treating acute myocarditis in children admitted to intensive care units

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What is this trial about?

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

This study focuses on children with acute myocarditis, which is a condition where the heart muscle becomes inflamed. The research evaluates the effectiveness of a medication called Anakinra compared to placebo, given along with standard medical care. The purpose is to see if this treatment can help restore normal heart function in children who are being treated in intensive care units.

The medication Anakinra is given through subcutaneous injection (an injection under the skin) for 7 days. The treatment involves daily doses of 100 mg of the medication. Some patients will receive sodium chloride solution as a placebo treatment instead of the active medication.

The study monitors how well the heart functions after starting the treatment, particularly focusing on the heart's ability to pump blood effectively. The research team will track the children's progress for up to 6 months after treatment begins, checking their heart function and watching for any side effects that might occur during the treatment period.

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

    Initial treatment phase

    You will receive either anakinra or a placebo (inactive substance) through subcutaneous injection (under the skin), along with standard care treatment

    The medication Kineret (anakinra) comes in pre-filled syringes containing 100 mg/0.67 ml solution

    Treatment begins upon admission to the Intensive Care Unit (ICU)

  2. Step 2

    First 3 days monitoring

    Your heart function will be checked using echocardiography (heart ultrasound) to measure heart pumping ability

    Blood tests will be performed at 24 hours, 48 hours, and 72 hours to measure NT proBNP and Troponin T levels (markers of heart function)

    Regular EKG (heart rhythm) monitoring will be conducted

  3. Step 3

    7-day follow-up

    Additional heart ultrasound examination will be performed

    Blood tests will be repeated to check heart function markers

    Continued monitoring of heart rhythm

  4. Step 4

    28-day assessment

    Heart function will be evaluated again using ultrasound

    Assessment of overall recovery and treatment response

  5. Step 5

    Long-term monitoring

    Regular check-ups will continue for 6 months after treatment start

    Monitoring for any side effects such as hypersensitivity (allergic reactions), neutropenia (low white blood cell count), or liver-related changes

    Final evaluation of treatment outcomes at 6 months

Who can join the trial?

6 criteria

  • You must be a child between 3 months and 18 years old
  • You must be receiving care in an Intensive Care Unit (ICU) for acute myocarditis with:
    • Reduced heart pumping function (left ventricle ejection fraction below 50%)
    • Elevated levels of heart protein (troponin T) in blood that is more than 1.5 times higher than normal
    • Your parent or legal guardian must sign an informed consent form
    • If you are old enough to understand, you must also agree to participate in the study
    • Both boys and girls can participate in this study

Who cannot join the trial?

14 criteria

  • Age below 1 month or above 18 years
  • Known allergic reaction to Anakinra or similar medications
  • Active bacterial infection (infection caused by bacteria)
  • Severe kidney failure (when kidneys don't work properly to filter waste from blood)
  • Current participation in other clinical trials
  • Immunodeficiency (weakened immune system)
  • History of chronic heart disease (long-term heart conditions)
  • Pregnancy or breastfeeding
  • Unable to provide informed consent (through parents or legal guardians)
  • Presence of other serious medical conditions that could interfere with the study
  • Recent use of medications that could interact with the study drug
  • Blood disorders that increase risk of bleeding
  • History of liver disease (conditions affecting the liver)
  • Known or suspected genetic disorders affecting the heart
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Investigated drugs

Anakinra is a medication that works by blocking a protein in the body that causes inflammation. It is used to reduce inflammation in various conditions. In this trial, it is being studied for treating acute myocarditis (inflammation of the heart muscle) in children. The medication is given in addition to standard medical care to help improve heart function in children who are being treated in intensive care units.

What is already known about the treatment

Anakinra - A prescription medication administered through subcutaneous injection that belongs to the class of biological response modifiers known as interleukin-1 (IL-1) receptor antagonists. This medication works by blocking the activity of IL-1, a protein in the body that causes inflammation, making it effective in treating various inflammatory conditions including myocarditis, particularly in pediatric patients. Currently well-established in medical practice, Anakinra is being studied in clinical trials for treating acute myocarditis in children, where it's used alongside standard care to help restore heart muscle function. The medication's ability to rapidly suppress inflammation makes it particularly valuable in intensive care settings where quick intervention is crucial for patient recovery.

Investigated diseases

Pediatric Acute Myocarditis - An inflammatory condition affecting the heart muscle in children. The disease occurs when the heart muscle becomes inflamed, causing it to function less effectively. It typically develops suddenly and can affect the heart's ability to pump blood properly. The condition causes the heart muscle to become weakened and enlarged. During the acute phase, the heart's pumping efficiency (measured as ejection fraction) often decreases significantly. The inflammation can affect different parts of the heart muscle and may lead to changes in heart rhythm.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521478-32-00Protocol codeAPHP230825Estimated enrolment110 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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