Pulse corticosteroids or/and Immunoglobulins to treat fulminant Myocarditis: a double-blind randomized controlled adaptive trial (The CORIUM study)

Fulminant myocarditis

- A hierarchical composite outcome assessed at day 28 of mortality or heart transplantation/VAD/persisting t-MCS and the number of days alive without t-MCS and inotropes within the 28 days following randomization

Mortality at day 28/60/90, - VAD or/and heart transplant at day 28/60/90, - Number of t-MCS-free days at day 28, - Number of inotropes-free days at day 28, - Time to improvement in left ventricular function assessed by echocardiography at D3/D7/D14/D28 following randomization, - Time to normalize troponin and N-terminal pro–B-type natriuretic peptide within 14 days after randomization, - Incidence of drugs side effects (nosocomial infections, significant gastrointestinal bleeding, renal insufficiency, acute delirium leading to the use of neuroleptic agents), - Proportion of patients with left ventricular ejection fraction (LVEF) < 55% and/or left ventricular dilatation at 28-day, - Proportion of patients with at least one episode of ventricular arrhythmia at day-28, - Proportion of patients with at least one episode of atrioventricular block (degree II and III) or sinoatrial, atrioventricular or intraventricular block, - The proportion of patients with LVEF<55%, left ventricular dilatation, and late gadolinium enhancement at 6 months evaluated by cardiac magnetic resonance imaging

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