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

NCT05974462 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-04-17

No results posted yet for this study

Summary

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

  • Acute Myocarditis

Interventions

DRUG

Methylprednisolone 125 MG

125 mg daily for 3 days diluted in saline solution 250 mL

OTHER

IV saline solution 0.9%

Saline solution 0.9% 250 mL

Sponsors & Collaborators

  • Niguarda Hospital

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Caroline Van de Heyning · University Hospital, Antwerp

  • Enrico Ammirati · Niguarda Hospital Milano

  • Nicole Sturkenboom · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2026-10-01
Completion
2028-10-01

Countries

  • Belgium
  • Italy
  • Slovenia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974462 on ClinicalTrials.gov