MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
Status:
Recruiting
Trial end date:
2028-10-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to demonstrate the efficacy of pulsed intravenous
methylprednisolone in a single-blind randomized controlled trial versus standard therapy in
patients with acute myocarditis and a mildly reduced LVEF.
The main question[s] it aims to answer are:
- is there an increase in LVEF (≥55% or an absolute increase in LVEF ≥ 10%) on
echocardiogram after 5 days from randomization in patients treated with pulsed
corticosteroid therapy vs. standard therapy?
- is there a reduction in the proportion of patients with LVEF < 55% AND/OR LV dilation on
a 6-month CMRI in patients treated pulsed corticosteroid therapy vs. standard therapy?
- To assess the effect of corticosteroids on the occurrence of the combined endpoint(1)
all-cause death or (2) HTx or (3) long-term LVAD implant or (4) first rehospitalization
due to HF or ventricular arrhythmias, or advanced AV block.
Participants will be randomized in two arms in a 1:1 ratio. The experimental group will
receive pulsed corticosteroid therapy on top of the standard therapy and patients in the
placebo group will be treated with a saline solution on top of their standard therapy. All
other tests are executed according to standard of care.