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MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
Sponsor: University Hospital, Antwerp
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2024-05-24
Completion Date
2028-10-01
Last Updated
2025-04-17
Healthy Volunteers
No
Conditions
Interventions
Methylprednisolone 125 MG
125 mg daily for 3 days diluted in saline solution 250 mL
IV saline solution 0.9%
Saline solution 0.9% 250 mL
Locations (19)
Antwerp University Hospital
Edegem, Antwerp, Belgium
Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis)
Aalst, Belgium
Middelheim Ziekenhuis
Antwerp, Belgium
Jessa ziekenhuis
Hasselt, Belgium
Universitair ziekenhuis Leuven
Leuven, Belgium
Niguarda Hospital
Milan, Milan, Italy
Azienda USL Toscane SUD Est
Arezzo, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Careggi University Hospital
Florence, Italy
Alessandro Manzoni hospital
Lecco, Italy
San Raffaele Hospital
Milan, Italy
Ospedale Maggiore di Milano
Milan, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
University Medical Centre of Ljubljana
Ljubljana, Slovenia
Hospital Universitario A Coruña (CHUAC)
A Coruña, Spain