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

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.

NCT Number	NCT04654988
Lead Sponsor	Medical University of Warsaw
Conditions	Myocarditis, Heart Failure, Endomyocardial Biopsy, Cardiomyopathies, Secondary, Immunosuppression
Enrollment	100 participants
Start Date	2022-12-01
Primary Completion	2027-09-30 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2024-03-28