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Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.

Study acronym: IMPROVE-MC
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 9 of 48 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 8 more changesShow less
    • Primary completion date: Mar 31, 2026 to Sep 30, 2027
    • Start date changed from estimate of May 1, 2022 to Dec 1, 2022
    • Primary endpoint revised
    • Study completion date: Sep 30, 2026 to Mar 30, 2028
    • Eligibility criteria expanded, about 291 words
    • Secondary endpoints: 30 to 48
    • Study description shortened, about 120 words
    • Site details revised
  3. Start date: Dec 1, 2021 to May 1, 2022v3
  4. Start date: Apr 1, 2021 to Dec 1, 2021v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Myocarditis can result in numerous complications, but there is paucity of data regarding optimal therapy, short- and long-term effects of possibly effective immunosuppressive therapy. The IMPROVE-MC study will provide high-quality scientific data about efficacy and safety of immunosuppressive therapy, non-invasive (MRI, biomarkers) and invasive diagnostics tests (endomyocardial biopsy), and prognosis in myocarditis. The objective of this multicenter, prospective, randomized, double-blind placebo-controlled trial is to assess the efficacy and safety of 12 - month treatment with prednisone and azathioprine comparing to placebo on top of guideline-recommended medical therapy in patients with biopsy-proven virus negative myocarditis or inflammatory cardiomyopathy and reduced ejection fraction (LVEF ≤ 45%). The study will also assess persistence of the treatment effects after 12 months.
Trial Details
NCT Number NCT04654988
Lead Sponsor Medical University of Warsaw
Conditions
(from sponsor)		 Myocarditis, Heart Failure, Endomyocardial Biopsy, Cardiomyopathies, Secondary, Immunosuppression
Related terms Cardiomyopathies, Heart Failure, Myocarditis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov