A multicenter, randomized, double-blind, placebo-controlled TRial evaluating Immunosuppressive treatment in patients with chronic virus-Negative Inflammatory cardiomyopaThY (TRINITY trial)
Key facts
- Where
- Bad Nauheim, Berlin, Essen, Frankfurt Am Main, Freiburg im Breisgau, Goettingen, Greifswald, Hamburg, Heidelberg, Luebeck, Munich és Regensburg, NémetországSee the 13 sites
- Phase
- 2/3. fázis
Where in Németország
- Kerckhoff-Klinik GmbHBad Nauheim, NémetországNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, NémetországNo longer taking part
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, NémetországNo longer taking part
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországNo longer taking part
- Universitaetsmedizin GoettingenGoettingen, NémetországNo longer taking part
- Universitaetsmedizin Greifswald KöRGreifswald, NémetországNo longer taking part
- University Medical Center Hamburg-EppendorfHamburg, NémetországNo longer taking part
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországNo longer taking part
- University Of LuebeckLuebeck, NémetországNo longer taking part
- Klinikum der Universitaet Muenchen AöRMunich, NémetországNo longer taking part
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországNo longer taking part
- Universitaetsklinikum Regensburg AöRRegensburg, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Klinikum der Universitaet Muenchen AöR
- Trial code
- EU 2024-512451-20-00
- Record updated
- 2024. október 14.
- Original description
To assess the clinical benefit with respect to absolute increase in LVEF (metric and binary co-primary endpoints assessed by MRI core lab) of immunosuppressive treatment with MMF and prednisolone compared to placebo at 12 months follow-up.Read full original descriptionShow less
To assess the clinical benefit with respect to absolute increase in LVEF (metric and binary co-primary endpoints assessed by MRI core lab) of immunosuppressive treatment with MMF and prednisolone compared to placebo at 12 months follow-up.
Inclusion: 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.
Exclusion: 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; Known systemic inflammatory disease; 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.