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RECRUITING
NCT05974462
PHASE3

MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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

Interventions

DRUG

Methylprednisolone 125 MG

125 mg daily for 3 days diluted in saline solution 250 mL

OTHER

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