Single-blind, investigator-initiated, randomized, controlled trial to assess the safety and efficacy of intravenous corticosteroid therapy to treat patients with acute myocarditis with mildly reduced left ventricular ejection fraction

Acute myocarditis

The primary objective is to demonstrate an increase in the rate of the primary composite endpoint (LVEF >55% or increase of 10%) in patients treated with pulsed corticosteroid therapy vs. standard therapy and maximal supportive care.

The main secondary composite endpoint is defined as the reduction in the proportion of patients with LVEF<55% AND/OR LV dilation on 6-month cardiac magnetic resonance imaging (CMRI) (CMRI clips will be centrally reviewed in a blind fashion by readers), Proportion of patients with LV dilation on 6-months CMRI, Proportion of patients with LVEF<55% on 6-month CMRI, LGE burden (% of mass) on 6 month CMRI, Composite endpoint defined as the time from randomization to the first event ((1) all-cause death or (2) HTx or (3) long-term LVAD implantation, or (5) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block) occurring within 6 months and 2 years, Mortality: Time from randomization to all-cause death within 6 months and 2 years, Time from randomization tot hospitalization for heart failure within 6 months and 2 years, Composite endpoint of presence of NSVT OR burden of PVC`s>10% on 24 hour ECG ambulatory monitoring, performed at 6 months follow-up, Burden of PVCs (% of total heart beats) on 24 hour holtermonitoring, performed at 6 months follow-up, Presence of NSVT on 24 hour holtermonitoring performed at 6 months follow-up, Quality of life and health assessment at 2 and 6 months follow-up using the EuroQol 5-dimension, 5 level questionnaire, Recurrence of acute myocarditis at six months and 2 years, Hospitalization due to recurrence of AM, pericarditis or recurrence of chest pain or atrial fibrillation, In-hospital composite endpoint, defined as the proportion of patients who experience at least one of the following events during index hospitalization: 1. all-cause death, or 2. Htx, or 3. long-term LVAD implant, or 4. need for an upgrading of the t-MCS, or 5. a VT/VF treated with DC shock (excluding VT/VF in patients on t-MCS other than IABP., relative reduction of troponin levels after 5 days from randomization, Reduction in heart rate on ECG after 3 days from randomization, increase in LVEF on echocardiogram after 5 days from randomization, Number of days in the hospital, number of days on the ICU, Need for inotropes, number of days on t-MCS

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