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Study identifier: NCT05974462 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Acute Myocarditis  ·  Sponsor: University Hospital, Antwerp

PhasePhase 3
Planned participants174
Who can joinAll sexes, 18 Years to 69 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Caroline Van De Heyning, MD PhD  ·  +32 821 3538  ·  caroline.vandeheyning@uza.be

Nicole Sturkenboom, MD  ·  +32 821 3538  ·  nicole.sturkenboom@uza.be

Always discuss trial participation with your own doctor first.

Locations (19)

Antwerp University HospitalEdegem, Antwerp, BelgiumRecruiting
Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis)Aalst, BelgiumRecruiting
Middelheim ZiekenhuisAntwerp, BelgiumRecruiting
Jessa ziekenhuisHasselt, BelgiumRecruiting
Universitair ziekenhuis LeuvenLeuven, BelgiumRecruiting
Niguarda HospitalMilan, Milan, ItalyRecruiting
Azienda USL Toscane SUD EstArezzo, ItalyNot Yet Recruiting
Azienda Ospedaliera Papa Giovanni XXIIIBergamo, ItalyNot Yet Recruiting
ASST Spedali Civili di BresciaBrescia, ItalyNot Yet Recruiting
Careggi University HospitalFlorence, ItalyNot Yet Recruiting
Alessandro Manzoni hospitalLecco, ItalyNot Yet Recruiting
San Raffaele HospitalMilan, ItalyNot Yet Recruiting

+ 7 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05974462