Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05974462 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: MYTHS-MR
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 17, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 17 to 19v9
  2. Study sites: 16 to 17v8
  3. Site details revised at 2 of 16 sitesv7
  4. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Start date changed from estimate of Jan 1, 2024 to May 24, 2024
    • Study sites: 1 to 16
    • Interventions: IV saline solution 250 mL [Placebo] (Other), Methylprednisolone 125 MG [Solu-Medrol] (Drug) to IV saline solution 0.9% (Other), Methylprednisolone 125 MG (Drug)
    • Study description expanded, about 37 words
  5. Start date: Oct 1, 2023 to Jan 1, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 1 to 2
    • Study description revised
    v4
  2. Study sites: 0 to 1v3
  3. Study title shortened, about 23 words
    • Study description expanded, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05974462
Lead Sponsor University Hospital, Antwerp
Collaborators: Niguarda Hospital
Conditions
(from sponsor)		 Acute Myocarditis
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov