ANAKINRA for Acute myocarditis

Inclusion criteria

• {"criterion_text":"- Children from ≥ 3 months to < 18 years of age\n- Hospitalized in the Intensive Care Unit (ICU) for acute myocarditis defined as : - a reduced left ventricle ejection fraction below 50% and - troponin T rise (>1.5x normal range)\n- Signed informed consent by legal representative and patient according to the legislation."}

Exclusion criteria

• {"criterion_text":"- Children weighing less than 5 Kgs\n- Anti TNF-α within the past 14 days\n- Malignancy or history of malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study\n- Ongoing or recent use of any other medication Known inhibitors/inducers of cytochrome P450\n- \tPatients with increased risk of Tuberculosis (TB ) infection -\tRecent tuberculosis infection or with active TB o\tClose contact with a patient with TB o\tPatients recently arrived less than 3 months from a country with high prevalence of TB o\tA chest radiograph suggestive of TB\n- \tPatients with overt concomitant bacterial infection\n- \tPatients with overt concomitant bacterial infection\n- \tPatients with any type of immunodeficiency or cancer\n- Inability of the legal representative (and the patient, when applicable) to understand the national language (French)\n- Pregnancy** or breastfeeding\n- No affiliation to the Social Security\n- Current enrollment in another clinical trial\n- Known anterior cardiomyopathy or operated cardiopathy\n- Neutropenia (< 1,5 × 10^9 /L).\n- Known hypersensitivity to Anakinra or any of its excipients (citric acid anhydrous, sodium chloride, disodium EDTA dihydrate, polysorbate 80, E. coli derived proteins)\n- Administration of a live vaccine in the 4 weeks prior to inclusion\n- Hepatitis B infection, defined as positive HBsAg and/or detectable HBV DNA (PCR). Due to the urgent need to start treatment, inclusion may occur before hepatitis B screening results are available. If hepatitis B infection is subsequently confirmed, the study treatment will be immediately discontinued."}

Primary endpoints

• {"endpoint_text":"- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.","definition_or_measurement_approach":"Recovery defined as LVEF ≥ 50% measured by echocardiography at day 3 after treatment initiation. Patients who die within the first 3 days or who still require ECMO at day 3 are considered failures."}

Secondary endpoints

• {"endpoint_text":"- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation respectively will be considered as a failure (i.e, LVEF < 50%). Patients who still require ECMO at 7 and 28 days after treatment initiation respectively will also be considered as failure (i.e., LVEF < 50%).","definition_or_measurement_approach":"Recovery defined as LVEF ≥ 50% by echocardiography at days 7 and 28. Death or heart transplant within the respective time window or ongoing ECMO are considered failures."}
• {"endpoint_text":"- Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation 3- Proportion of children requiring ECMO within the first 3 days after treatment initiation","definition_or_measurement_approach":"Time-to-event endpoint measuring time from treatment initiation to first documentation of LVEF ≥ 50% within 3 days. Also records proportion requiring ECMO within first 3 days."}
• {"endpoint_text":"- Proportion of children requiring ECMO within the first 3 days after treatment initiation","definition_or_measurement_approach":"Proportion of participants requiring extracorporeal membrane oxygenation (ECMO) within 3 days of treatment initiation."}
• {"endpoint_text":"- Proportion of children who undergo heart transplant within 6 months after treatment initiation","definition_or_measurement_approach":"Proportion undergoing heart transplantation within 6 months after treatment initiation."}
• {"endpoint_text":"- Time to all-cause death within 6 months after treatment initiation","definition_or_measurement_approach":"Time from treatment initiation to death from any cause within 6 months."}
• {"endpoint_text":"- Time to cardiovascular-related death within 6 months after treatment initiation","definition_or_measurement_approach":"Time from treatment initiation to death due to cardiovascular causes within 6 months."}
• {"endpoint_text":"- Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)","definition_or_measurement_approach":"Proportion of participants experiencing drug-related adverse events including hypersensitivity, neutropenia, liver enzyme elevation, etc."}
• {"endpoint_text":"- a-\t o\tNT proBNP at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o\tTroponin T at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o\tProportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation b-\t o\tNT proBNP at 7 days following treatment initiation o\tTroponin T at 7 days following treatment initiation o\tProportion of children with ventricular tachyca","definition_or_measurement_approach":"Cardiac biomarkers (NT-proBNP, Troponin T) measured at baseline, 24h, 48h, 72h and at 7 days; EKG-assessed ventricular tachycardia at same timepoints. Exact laboratory/assay methods not specified in the Part I JSON."}

France

Earliest CTIS Part Ii Submission Date

26-08-2025

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

9

Number Of Sites

11

Number Of Participants

110

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"DGOS (Direction Générale de l'Offre de Soins), Ministry of Health, France","duties_or_roles":"Source of monetary support / funding","organisation_type":"Government / Ministry of Health"}