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CMP-MYTHiCNCT06158698

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved 2 years 10 months later.

See at-risk trials from Niguarda Hospital

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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 2, 2026 to Mar 2, 2029 Show 6 more changesShow less
    • Eligibility criteria expanded, about 4 words
    • Study completion pushed from May 2, 2028 to Aug 31, 2029
    • Study sites: 10 to 12
    • Secondary endpoints: details revised at 5 of 9 entries
    • Publications: details revised at 11 of 11 entries
    • Study description expanded, about 3 words
  2. Site details revised at 7 of 10 sitesv3
  3. Site details revised at 2 of 10 sitesv2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Patients alive and free of any worsening features (clinical, arrhythmic burden and imaging outcome) AND that show at least one of the signs of improvements (IMAGING or ARRHYTMIC improvements).
Timeframe: 6 months from randomization
Worsening imaging outcomes
Timeframe: 6 months from randomization

Secondary (9)

LVEF change on echocardiogram.
LVEF change on CMRI
Evidence of dysfunction and/or dilation on CMRI
Clinical secondary endpoints
Mortality
Show 4 moreShow less
Time to HF or arrhythmic events
Changes on ambulatory ECG monitoring
Changes in Quality of life
Need for immunosuppression

Arms and interventions

ColchicineExperimental

Patients treated with colchicine 0.5-1 mg (1 mg if tolerated) for 6 months.

PlaceboPlacebo comparator

Patients treated with placebo tablets.

Drugs: Colchicine

Other: Placebo

Sites

12 sites in 1 country