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MYTHS - MYocarditis THerapy With Steroids

NCT05150704 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-07-31

No results posted yet for this study

Summary

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

  • Myocarditis Acute

Interventions

DRUG

Methylprednisolone

Pulsed corticosteroid therapy (methylprednisolone 1 g IV qd for 3 days diluted in saline solution 250 mL) on top of standard therapy and maximal supportive care

DRUG

saline solution

Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • University of Milano Bicocca

    collaborator OTHER

  • Regione Lombardia

    collaborator OTHER

  • Niguarda Hospital

    lead OTHER

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
2021-10-07
Primary Completion
2028-03-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Finland
  • Italy
  • Slovenia
  • Spain
  • Sweden

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 NCT05150704 on ClinicalTrials.gov