Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.
Status:
Not yet recruiting
Trial end date:
2026-09-30
Target enrollment:
Participant gender:
Summary
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.