ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS. ANAPEM

Condition studied

PEDIATRIC ACUTE MYOCARDITIS

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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%)., 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, Proportion of children requiring ECMO within the first 3 days after treatment initiation, Proportion of children who undergo heart transplant within 6 months after treatment initiation, Time to all-cause death within 6 months after treatment initiation, Time to cardiovascular-related death within 6 months after treatment initiation, Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…), a- o NT proBNP at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o Troponin T at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation b- o NT proBNP at 7 days following treatment initiation o Troponin T at 7 days following treatment initiation o Proportion of children with ventricular tachyca