Actively Recruiting
MYTHS - MYocarditis THerapy With Steroids
Led by Niguarda Hospital · Updated on 2025-07-31
288
Participants Needed
49
Research Sites
373 weeks
Total Duration
On this page
Sponsors
N
Niguarda Hospital
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
MYTHS - MYocarditis THerapy With Steroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to hospital for suspected acute myocarditis
- Age between 18 and 69 years
- Acute heart failure with suspected acute myocarditis based on NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL
- Left ventricular ejection fraction less than 41% and left ventricular end diastolic diameter less than 56 mm on echocardiogram
- Elevated troponin levels at least three times the upper reference limit at randomization
- Cardiac symptoms started within 3 weeks before randomization
- Coronary artery disease excluded by angiogram in patients aged 46 years or older if myocarditis not histologically proven
- Randomization within 120 hours of hospital admission
You will not qualify if you...
- Known systemic autoimmune disorder or other conditions requiring immunosuppression at randomization except cardiac sarcoidosis or giant cell myocarditis
- Current chronic oral or intravenous corticosteroid or other immunosuppressive therapies
- Allergy or contraindication to corticosteroids
- Persistent peripheral eosinophilia above 7% or known hypereosinophilic syndrome at randomization
- Myocarditis related to anti-cancer immune checkpoint inhibitor therapy
- Previous chronic cardiac disease except recovered myocarditis
- Active bacterial or fungal infection or known chronic infections like HIV or tuberculosis
- Out-of-hospital cardiac arrest
- Temporary mechanical circulatory support started more than 48 hours before randomization
- Clinically judged too sick for mechanical circulatory support
- Echocardiographic signs of other cardiac diseases such as endocarditis
- Participation in another clinical trial
- Pregnant women or positive pregnancy test for women aged 18 to 50
- Any other significant disease with expected life expectancy under 12 months or that may affect trial participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
University of Texas
Houston, Texas, United States, 77204
Not Yet Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
4
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Not Yet Recruiting
5
Medical University of Graz
Graz, Austria
Actively Recruiting
6
Medical University Innsbruck
Innsbruck, Austria
Not Yet Recruiting
7
Medical University of Wien
Vienna, Austria
Actively Recruiting
8
Onze Lieve Vrouwziekenhuis
Aalst, Belgium
Actively Recruiting
9
Antwerp University Hospital
Edegem, Belgium
Actively Recruiting
10
Jessa Hospital Hasselt
Hasselt, Belgium
Actively Recruiting
11
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
12
Masaryk University and St. Anne's University Hospital
Brno, Czechia
Actively Recruiting
13
Charles University in Prague and General University Hospital
Prague, Czechia
Actively Recruiting
14
Institute for Clinical and Experimental Medicine - IKEM
Prague, Czechia
Actively Recruiting
15
Heart and Lung Center, Helsinki University Hospital
Helsinki, Finland
Not Yet Recruiting
16
AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
Ancona, Italy
Actively Recruiting
17
ASST Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
18
Policlinico S.Orsola-Malpighi
Bologna, Italy
Actively Recruiting
19
ASST Spedali Civili
Brescia, Italy
Actively Recruiting
20
Azienda Ospedaliera "G.Brotzu"
Cagliari, Italy
Actively Recruiting
21
P.O. SS. Annunziata Chieti -ASL 2 Abruzzo
Chieti, Italy
Actively Recruiting
22
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Actively Recruiting
23
Ospedale Policlinico San Martino, IRCCS
Genova, Italy
Actively Recruiting
24
Azienda Socio-Sanitaria Territoriale (ASST) di Lecco
Lecco, Italy
Actively Recruiting
25
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
26
Centro Cardiologico Monzino
Milan, Italy
Actively Recruiting
27
ASST Monza, Ospedale San Gerardo
Monza, Italy
Actively Recruiting
28
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
Naples, Italy
Actively Recruiting
29
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Actively Recruiting
30
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
31
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Actively Recruiting
32
Azienda Ospedaliera San Camillo Forlanini di Roma
Roma, Italy
Actively Recruiting
33
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
34
Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte
Siena, Italy
Actively Recruiting
35
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Actively Recruiting
36
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine, Italy
Actively Recruiting
37
University Medical Centre Ljubljana
Ljubljana, Slovenia
Actively Recruiting
38
Complexo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Actively Recruiting
39
Bellvitge University Hospital
Barcelona, Spain
Actively Recruiting
40
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Actively Recruiting
41
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
42
Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
43
Hospital General Universitario Gregorio Marañón in Madrid
Madrid, Spain
Actively Recruiting
44
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Actively Recruiting
45
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
46
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
47
Sahlgrenska Universitetssjukhuset
Göthenburg, Sweden
Not Yet Recruiting
48
Lund University and Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
49
Karolinska Universitetssjukhuset
Stockholm, Sweden
Not Yet Recruiting
Research Team
E
Enrico Ammirati, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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