MYTHS - MYocarditis THerapy With Steroids
Condition(s) studied
Investigational drug(s) / intervention(s)
Methylprednisolone: Pulsed corticosteroid therapy (methylprednisolone 1 g IV qd for 3 days diluted in saline solution 250 mL) on top of standard therapy and maximal supportive care
saline solution: Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.
Study summary
This is a phase III, multi-center international, single blind randomized controlled trial to test the efficacy of pulsed intravenous (IV) methylprednisolone versus standard therapy on top of maximal support in patients with Acute myocarditis (AM).
Eligibility
Primary outcome measure(s)
- Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, need for an upgrading of the t-MCS, VT/VF treated with DC shock, first rehospitalization due to HF or ventricular arrhythmias, or AV block. — 6 months from patients enrollment
The Primary composite endpoint is defined as the time from randomization to the first event occurring within 6 months on patients treated with pulsed corticosteroid therapy vs. standard therapy and maximal supportive care, among: (1) all-cause death, or (2) heart transplantation (HTx), or (3) long-term left ventricular assist device (LVAD) implant, or (4) need for an upgrading of the t-MCS, or (5) a ventricular tachycardia (VT)/fibrillation (VF) treated with direct current (DC) shock (excluding VT/VF in patients on t-MCS other than IABP), or (6) first rehospitalization due to HF or ventricular arrhythmias, or advanced Atrioventricular (AV) block.
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Diego | San Diego | California | Recruiting |
| University of Texas | Houston | Texas | Not Yet Recruiting |
| University of Virginia | Charlottesville | Virginia | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | Not Yet Recruiting |
| Medical University of Graz | Graz | Austria | Recruiting |
| Medical University Innsbruck | Innsbruck | Austria | Not Yet Recruiting |
| Medical University of Wien | Vienna | Austria | Recruiting |
| Onze Lieve Vrouwziekenhuis | Aalst | Belgium | Recruiting |
| Antwerp University Hospital | Edegem | Belgium | Recruiting |
| Jessa Hospital Hasselt | Hasselt | Belgium | Recruiting |
| University Hospitals Leuven | Leuven | Belgium | Recruiting |
| Masaryk University and St. Anne's University Hospital | Brno | Czechia | Recruiting |
| Charles University in Prague and General University Hospital | Prague | Czechia | Recruiting |
| Institute for Clinical and Experimental Medicine - IKEM | Prague | Czechia | Recruiting |
| Heart and Lung Center, Helsinki University Hospital | Helsinki | Finland | Not Yet Recruiting |
| AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona | Ancona | Italy | Recruiting |
| ASST Papa Giovanni XXIII | Bergamo | Italy | Recruiting |
| Policlinico S.Orsola-Malpighi | Bologna | Italy | Recruiting |
| ASST Spedali Civili | Brescia | Italy | Recruiting |
| Azienda Ospedaliera "G.Brotzu" | Cagliari | Italy | Recruiting |
| P.O. SS. Annunziata Chieti -ASL 2 Abruzzo | Chieti | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Recruiting |
| Ospedale Policlinico San Martino, IRCCS | Genova | Italy | Recruiting |
| Azienda Socio-Sanitaria Territoriale (ASST) di Lecco | Lecco | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| Centro Cardiologico Monzino | Milan | Italy | Recruiting |
| ASST Monza, Ospedale San Gerardo | Monza | Italy | Recruiting |
| Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Recruiting |
| Fondazione Toscana Gabriele Monasterio | Pisa | Italy | Recruiting |
| Azienda Ospedaliera San Camillo Forlanini di Roma | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte | Siena | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino | Torino | Italy | Recruiting |
| Presidio Ospedaliero Universitario "Santa Maria della Misericordia" | Udine | Italy | Recruiting |
| University Medical Centre Ljubljana | Ljubljana | Slovenia | Recruiting |
| Complexo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | Spain | Recruiting |
| Bellvitge University Hospital | Barcelona | Spain | Recruiting |
| Hospital de La Santa Creu I Sant Pau | Barcelona | Spain | Recruiting |
+ 9 more sites — see the full list on the official registry below.
More Niguarda Hospital trials in Italy
Other trials for the same condition
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 NCT05150704 on ClinicalTrials.gov ↗ ← All trials in Italy