Patients presenting with acute myocarditis proven by cardiac magnetic resonance imaging (CMRi) or by histological evidence on endomyocardial biopsy (EMB)
Conditions
Brief summary
Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16% between baseline (D-2) and 6 months (M6) follow up. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months
Detailed description
Changes in LVEF ≥ 50% at 6 months using 2D trans-thoracic echocardiography (2D-TTE) between baseline (D-2 maximum) and 6 months (M6), Changes in Global Longitudinal Strain (GLS) ≥ -16% at 6 months using 2D-TTE between baseline (D-2 maximum) and 6 months (M6), All-cause mortality, Hospitalization for heart failure, Sustained ventricular arrhythmia, Heart transplantation, Heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella device or Left Ventricular Assistance Devices (LVAD), Time to recurrence of acute myocarditis with LV dysfunction, Adverse events and serious adverse events especially nosocomial infectious and duration of treatment by insulin, Compliance to the treatment (premature ending of the treatment or proportion of non-administered doses of the treatment), Increased quality of life evaluated by Minnesota living with heart failure questionnaire (MLHFQ) during follow up
Interventions
DRUGPlacebo of methylprednisolone (glucose 5%)
DRUGcomprimé sécable
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16% between baseline (D-2) and 6 months (M6) follow up. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in LVEF ≥ 50% at 6 months using 2D trans-thoracic echocardiography (2D-TTE) between baseline (D-2 maximum) and 6 months (M6), Changes in Global Longitudinal Strain (GLS) ≥ -16% at 6 months using 2D-TTE between baseline (D-2 maximum) and 6 months (M6), All-cause mortality, Hospitalization for heart failure, Sustained ventricular arrhythmia, Heart transplantation, Heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella device or Left Ventricular Assistance Devices (LVAD), Time to recurrence of acute myocarditis with LV dysfunction, Adverse events and serious adverse events especially nosocomial infectious and duration of treatment by insulin, Compliance to the treatment (premature ending of the treatment or proportion of non-administered doses of the treatment), Increased quality of life evaluated by Minnesota living with heart failure questionnaire (MLHFQ) during follow up | — |
Countries
France
Outcome results
None listed