RecruitingPhase 3NCT05974462

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

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


Sponsor

University Hospital, Antwerp

Enrollment

174 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This European trial (MYTHS-MR) is testing whether giving high-dose IV methylprednisolone — a powerful anti-inflammatory steroid — within the first few days of hospitalization for acute myocarditis can help the heart recover faster compared to standard supportive care alone. Myocarditis is an inflammation of the heart muscle that mainly affects young people and can cause serious heart failure. Adults hospitalized with suspected acute myocarditis who have a mildly reduced heart pumping function (ejection fraction below 50%), elevated troponin, and symptoms starting within 3 weeks are eligible — those already on steroids, with known autoimmune disease, or with severe heart failure are excluded. Participation involves being randomly assigned to receive IV steroid infusions or a saline placebo for the first few days of hospitalization, along with echocardiograms, cardiac MRI at 6 months, and regular follow-up for 2 years. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylprednisolone 125 MG

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

OTHERIV 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

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NCT05974462


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