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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 22, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT04654988). This is a study registration, not published results. Lead sponsor: Medical University of Warsaw. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Myocarditis, Heart Failure, Endomyocardial Biopsy, Cardiomyopathies, Secondary, Immunosuppression. Interventions: DRUG: Prednisone; DRUG: Azathioprine; DRUG: Placebo Prednisone; DRUG: Placebo Azathioprine. Primary outcome measures: LVEF at 12 - months. , 12- months. Brief summary: 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.