Actively Recruiting
MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
Led by University Hospital, Antwerp · Updated on 2025-04-17
174
Participants Needed
19
Research Sites
227 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
N
Niguarda Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left ventricular ejection fraction (LVEF) below 50% and left ventricular end-diastolic diameter (LV-EDD) less than 56 mm on echocardiogram
- Increased troponin levels (3 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 or older if myocarditis is not confirmed by biopsy
- Randomization within 120 hours of hospital admission
- Endomyocardial biopsy optional based on local team decision
You will not qualify if you...
- Known systemic autoimmune disorder where immunosuppression is useful, except if diagnosed during hospitalization
- Current chronic oral or intravenous corticosteroid or other immunosuppressive therapy (excluding colchicine or NSAIDs)
- Allergy or contraindication to corticosteroids
- Persistent peripheral eosinophilia over 7% or known hypereosinophilic syndrome
- Myocarditis linked to immune checkpoint inhibitor therapy
- Previously known chronic cardiac disease except recovered myocarditis
- Active bacterial or fungal infection or suspected infection with high procalcitonin
- Known chronic infections such as HIV or tuberculosis
- Out-of-hospital cardiac arrest
- Echocardiogram signs of other cardiac diseases like endocarditis
- Participation in another clinical trial
- Pregnant women or positive pregnancy test in women aged 18-50
- Any serious disease with life expectancy less than 12 months or judged by investigator to interfere with trial
- If LVEF under 41%, NT-proBNP must be below 1600 pg/mL or BNP below 400 pg/mL; no NT-proBNP or BNP limits if LVEF 41%-<50%
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Antwerp University Hospital
Edegem, Antwerp, Belgium
Actively Recruiting
2
Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis)
Aalst, Belgium
Actively Recruiting
3
Middelheim Ziekenhuis
Antwerp, Belgium
Actively Recruiting
4
Jessa ziekenhuis
Hasselt, Belgium
Actively Recruiting
5
Universitair ziekenhuis Leuven
Leuven, Belgium
Actively Recruiting
6
Niguarda Hospital
Milan, Milan, Italy, 20125
Actively Recruiting
7
Azienda USL Toscane SUD Est
Arezzo, Italy
Not Yet Recruiting
8
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
9
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
10
Careggi University Hospital
Florence, Italy
Not Yet Recruiting
11
Alessandro Manzoni hospital
Lecco, Italy, 23900
Not Yet Recruiting
12
San Raffaele Hospital
Milan, Italy, 20132
Not Yet Recruiting
13
Ospedale Maggiore di Milano
Milan, Italy
Not Yet Recruiting
14
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
15
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Not Yet Recruiting
16
Policlinico Universitario Agostino Gemelli
Roma, Italy
Not Yet Recruiting
17
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Not Yet Recruiting
18
University Medical Centre of Ljubljana
Ljubljana, Slovenia
Actively Recruiting
19
Hospital Universitario A Coruña (CHUAC)
A Coruña, Spain, 15006
Not Yet Recruiting
Research Team
C
Caroline Van De Heyning, MD PhD
CONTACT
N
Nicole Sturkenboom, MD
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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