A multicenter, randomized, double-blind, placebo-controlled TRial evaluating Immunosuppressive treatment in patients with chronic virus-Negative Inflammatory cardiomyopaThY (TRINITY trial)

Prior treatment

• Recent major surgery within <6 weeks, recent ICD implantation within <6 weeks or recent CRT implantation within <3 months prior to baseline examinations
• Known coronary artery disease responsible for cardiac dysfunction (i.e., prior myocardial infarction, chronic total occlusion, persistent stenosis ≥70%)
• Contraindications to immunosuppressive treatment with MMF + corticosteroids

Other illness

• Known systemic inflammatory disease

Other

• Histopathological (as approved by the histopathology core lab) and/ or clinical evidence of acute lymphocytic myocarditis, sarcoidosis, GCM or eosinophilic myocarditis
• Pregnancy or lactation
• Inability to provide informed consent

• Age ≥18 years
• Medical therapy for HF at least 3 months but not longer than 10 years according to current guideline recommendations,
• Persistent reduction of LVEF <50% on routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion
• EMB with immunohistochemical evidence of lymphocytic myocarditis defined as ≥14 leukocytes/mm2 including up to 4 monocytes/mm2 with the presence of CD3 positive T-lymphocytes ≥7 cells/mm2 and increased MHC-II expression as approved by the histopathology core lab
• Absence of established cardiotropic virus infection in EMBs (i.e., enteroviruses, HHV-6, EBV, CMV, adenoviruses, parvovirus B19 >500 copies) as approved by the histopathology core lab
• Negative pregnancy test and the use of a highly effective contraceptive measure in women with childbearing potential (according to CTFG recommendations)
• Written informed consent