Not yet recruitingPHASE3INTERVENTIONAL

ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS

This study is investigating a new medicine, Anakinra, for children and teenagers (from 3 months to under 18 years old) who have a serious heart problem called acute myocarditis and are in intensive care. Acute myocarditis means the heart muscle is inflamed, making it harder for the heart to pump blood effectively. We believe that Anakinra might help reduce this inflammation and allow the heart to recover better. Children in the study will either receive Anakinra or a placebo (a dummy drug), in addition to their usual treatment. We'll be carefully watching to see if Anakinra helps their heart function improve quicker, especially within the first three days. This study aims to find better ways to help young patients with this serious condition.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

110

Start

01 Feb 2026

Estimated completion

01 Dec 2029

PEDIATRIC ACUTE MYOCARDITIS

What is this study about?

This study focuses on a serious heart condition in children and teenagers called acute myocarditis. Acute means it comes on suddenly, and myocarditis means inflammation of the heart muscle. When the heart muscle is inflamed, it can struggle to pump blood effectively around the body. Children with this condition are often very unwell and need care in an intensive care unit (ICU).

Doctors have noticed that a process in the body called 'inflammation' plays a big part in myocarditis. In this study, we are researching a medicine called Anakinra, which is thought to work by blocking some of these inflammatory processes. Our hypothesis is that by calming down this inflammation, Anakinra could help the heart muscle heal and start working properly again more quickly compared to just using the standard treatments currently available.

The main goal is to see if Anakinra helps children's heart function get back to normal within three days of starting treatment. We'll be using special heart scans to check this. We'll also be looking at other important things like how quickly their heart improves over a longer time, if fewer children need extreme medical support like a heart-lung machine (ECMO), and if it reduces the need for heart transplants. We also need to check for any side effects the medicine might cause.

Key takeaways

This study is testing a new medicine (Anakinra) for children with severe heart inflammation (acute myocarditis).
It aims to see if Anakinra helps the heart recover faster than usual treatment.
Children will receive either Anakinra or a placebo, plus their standard care.
Heart function will be closely monitored with scans and blood tests.
Participation lasts for 6 months with regular check-ups.
The study hopes to find better ways to treat this serious condition in children.

Who may be eligible?

This study is for children and young people between 3 months and under 18 years old. To join, they must be in intensive care because of acute myocarditis. This means their heart isn't pumping blood as strongly as it should (measured by something called 'ejection fraction' being below 50%) and they have high levels of a marker in their blood called troponin T, which indicates heart muscle damage.

There are several reasons why a child might not be able to join. For example, if they weigh less than 5 kg, have certain existing heart problems, or a very low number of white blood cells (called neutropenia). Also, if they have certain serious infections like Hepatitis B or active tuberculosis, or if they've recently had a 'live' vaccine, they can't take part. Children who have had certain types of cancer or other long-term illnesses that could affect their survival or ability to complete the study are also unable to join.

Finally, children cannot participate if they are allergic to Anakinra or any of its ingredients, or if they are currently taking part in another clinical trial. For all participants, a parent or legal guardian must understand and sign an informed consent form, and the patient themselves will also sign if they are old enough to understand.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 3 months and under 18 years old?
Is my child currently in intensive care for acute myocarditis with weak heart pumping?
Does my child weigh at least 5 kilograms?
Does my child NOT have certain other serious health issues, like specific infections or immune problems?
Has my child NOT received a 'live' vaccine in the last month?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be given either Anakinra or a placebo (a dummy medicine that looks like Anakinra) as an injection under the skin. They will receive this in addition to the standard treatments they are already getting for their heart condition. Neither you nor your child's doctors will know whether they are getting Anakinra or the placebo – this is called 'double-blind' and helps us get unbiased results.

Throughout the study, your child will have regular check-ups, including heart scans (echocardiograms) to measure how well their heart is pumping. Blood tests will also be taken often, especially in the first few days, to check heart markers and look for any side effects. These assessments will happen more frequently at the beginning of treatment and then at set times, like 7 days, 28 days, and up to 6 months after starting the treatment. The total duration of active follow up in the study will be for 6 months after treatment initiation.

Potential risks and benefits

Participating in this study might offer a potential benefit if Anakinra helps your child's heart recover faster and more fully than standard treatment alone. However, we don't know for certain if it will work, and there's also a chance your child might receive the placebo. Like all medicines, Anakinra can have side effects, which might include allergic reactions, changes in blood cell counts, or effects on the liver. The research team will monitor your child very carefully for any of these. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

Bicêtre Hospital - APHP, Pediatric intensive care unit
Verified postcode
Le Kremlin-Bicêtre, France

Common questions

What is acute myocarditis?

It's an illness where the heart muscle becomes inflamed, making it harder for the heart to pump blood around the body properly.

What is Anakinra?

Anakinra is a medicine that aims to reduce inflammation, which we think plays a big part in acute myocarditis.

Will my child definitely get the new medicine?

No, your child will either receive the new medicine (Anakinra) or a placebo (a dummy medicine) as part of the study. It's a 50/50 chance.

How long does the study last?

Your child will be closely monitored for 6 months after they start treatment in the study, with more frequent checks in the first few days and weeks.

What if we change our minds about participating?

You can withdraw your child from the study at any time without having to give a reason, and it won't affect their care.

How to find out more

Ramy CHARBEL, Study Principal Investigator

ramy.charbel@aphp.fr 01 45 21 32 05 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.