MYTHS - MYocarditis THerapy With Steroids

Part of paid clinical trials in San Diego, California.

Sponsor
Niguarda Hospital
Study ID
NCT05150704
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myocarditis Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 7, 2021
Status verified
Jul 2025
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    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
  • Placebo Comparator: Control arm
    Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.

Primary Outcome Measure

Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, need for an upgrading of the t-MCS, VT/VF treated with DC shock, first rehospitalization due to HF or ventricular arrhythmias, or AV block. [ Time Frame: 6 months from patients enrollment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92093
Eric D Adler, MD
University of TexasHoustonTexas77204
Angelo Nascimbene, MD
University of VirginiaCharlottesvilleVirginia22903
Antonio Abbate, MD
Virginia Commonwealth UniversityRichmondVirginia23284
Roshanak Markley, MD

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