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NCT05150704 · ClinicalTrials.gov registry record · Phase 3
MYTHS - MYocarditis THerapy With Steroids
A Phase 3 study of Myocarditis Acute, sponsored by Niguarda Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT05150704: Recruiting Phase 3 study of Myocarditis Acute, sponsored by Niguarda Hospital.
NCT05150704 is a Phase 3 study of Myocarditis Acute that is actively recruiting participants, run by Niguarda Hospital. The registered enrollment target is 288 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05150704, a Phase 3 study of Myocarditis Acute, is actively recruiting participants, sponsored by Niguarda Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
The Primary composite endpoint is defined as the time from randomization to the first event occurring within 6 months on patients treated with pulsed corticosteroid therapy vs. standard therapy and maximal supportive care, among: (1) all-cause death, or (2) heart transplantation (HTx), or (3) long-term left ventricular assist device (LVAD) implant, or (4) need for an upgrading of the t-MCS, or (5) a ventricular tachycardia (VT)/fibrillation (VF) treated with direct current (DC) shock (excluding
Conditions Studied
Interventions
- DRUG Methylprednisolone
- DRUG saline solution
Study Locations (20)
Other
- Medical University of Graz - Graz
- Medical University Innsbruck - Innsbruck
- Medical University of Wien - Vienna
- Onze Lieve Vrouwziekenhuis - Aalst
- Antwerp University Hospital - Edegem
- Jessa Hospital Hasselt - Hasselt
- University Hospitals Leuven - Leuven
- Masaryk University and St. Anne's University Hospital - Brno
- Charles University in Prague and General University Hospital - Prague
- Institute for Clinical and Experimental Medicine - IKEM - Prague
- Heart and Lung Center, Helsinki University Hospital - Helsinki
- AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona - Ancona
- ASST Papa Giovanni XXIII - Bergamo
- Policlinico S.Orsola-Malpighi - Bologna
- ASST Spedali Civili - Brescia
- Azienda Ospedaliera "G.Brotzu" - Cagliari
Virginia
- University of Virginia - Charlottesville
- Virginia Commonwealth University - Richmond
California
- University of California San Diego - San Diego
Texas
- University of Texas - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What NCT05150704 shows while recruiting
NCT05150704 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Myocarditis Acute appearing as the primary indexed condition, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT05150704 names 20 study sites across 4 states, led by Other, Virginia, California.
Frequently Asked Questions
What is clinical trial NCT05150704 about?
NCT05150704 is a clinical study titled "MYTHS - MYocarditis THerapy With Steroids". 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).
What is the current status of trial NCT05150704?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2021-10-07. Estimated completion is 2028-12.
What conditions does trial NCT05150704 study?
This clinical trial studies the following conditions: Myocarditis Acute.
What interventions are being tested in trial NCT05150704?
The interventions under investigation include: Methylprednisolone (DRUG), saline solution (DRUG).
Who is sponsoring clinical trial NCT05150704?
This trial is sponsored by Niguarda Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05150704 being conducted?
This trial has 20 study locations across California, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myocarditis Acute
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05150704's enrollment target sits among peer trials
288 1175th of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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