MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Left ventricular ejection fraction — Day 5
LVEF ≥55% or an absolute increase in LVEF≥10% on echocardiogram after 5 days from randomization (echocardiographic clips will be centrally reviewed in a blind fashion by readers).
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | Recruiting |
| Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis) | Aalst | Belgium | Recruiting |
| Middelheim Ziekenhuis | Antwerp | Belgium | Recruiting |
| Jessa ziekenhuis | Hasselt | Belgium | Recruiting |
| Universitair ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| Niguarda Hospital | Milan | Milan | Recruiting |
| Azienda USL Toscane SUD Est | Arezzo | Italy | Not Yet Recruiting |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | Not Yet Recruiting |
| ASST Spedali Civili di Brescia | Brescia | Italy | Not Yet Recruiting |
| Careggi University Hospital | Florence | Italy | Not Yet Recruiting |
| Alessandro Manzoni hospital | Lecco | Italy | Not Yet Recruiting |
| San Raffaele Hospital | Milan | Italy | Not Yet Recruiting |
| Ospedale Maggiore di Milano | Milan | Italy | Not Yet Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Not Yet Recruiting |
| Fondazione Toscana Gabriele Monasterio | Pisa | Italy | Not Yet Recruiting |
| Policlinico Universitario Agostino Gemelli | Roma | Italy | Not Yet Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale | Udine | Italy | Not Yet Recruiting |
| University Medical Centre of Ljubljana | Ljubljana | Slovenia | Recruiting |
| Hospital Universitario A Coruña (CHUAC) | A Coruña | Spain | Not Yet Recruiting |
More University Hospital, Antwerp trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05974462 on ClinicalTrials.gov ↗ ← All trials in Spain