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

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What is this study about?

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.

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 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 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 28-day assessment

Heart function will be evaluated again using ultrasound

Assessment of overall recovery and treatment response

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
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Ggnsfd Haebwzvejxo Uvchkzauosmqt Payna Pfueqleczfe Ek Ngjlbjibrqdv Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.09.2025

Trial locations

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.

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 ID:
2025-521478-32-00
Protocol code:
APHP230825
Trial Phase:
Therapeutic confirmatory (Phase III)

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