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

Recruiting Phase 3 Interventional Study
Acute Myocarditis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 69
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
University Hospital, Antwerp · Other
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About This Trial
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 rand…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * LVEF\<50% and LV-EDD\<56 mm (parasternal long-axis view) on echocardiogram; * Increased troponin (3x URL) at the time of randomization; * Clinical onset of cardiac symptoms within 3 weeks from randomization; * Excluded coronary artery disease by coronary angiogram in subjects …
Contacts

Caroline Van De Heyning, MD PhD

+32 821 3538

caroline.vandeheyning@uza.be

CONTACT

Nicole Sturkenboom, MD

+32 821 3538

nicole.sturkenboom@uza.be

CONTACT