Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy
Megadott ok: Premature end of recruitment due to lack of eligible patients. Within two years of recruitment only nine patients could be randomized out of 130 required patients as per trial protocol.
Key facts
- Where
- Bad Nauheim, Berlin, Essen, Frankfurt, Freiburg im Breisgau, Göttingen, Greifswald, Hamburg, Heidelberg, Lübeck, Munich, München és Regensburg, NémetországSee the 14 sites
- Phase
- 2/3. fázis
Where in Németország
- Kerckhoff-Klinik GmbHBad Nauheim, NémetországNo longer taking part
- Charite - University Hospital BerlinBerlin, NémetországNo longer taking part
- University Hospital EssenEssen, NémetországNo longer taking part
- UHF- Universitäres Herz- und GefässzentrumFrankfurt, NémetországNo longer taking part
- University Hospital Freiburg-Bad KrozingenFreiburg im Breisgau, NémetországNo longer taking part
- Universitätsmedizin GöttingenGöttingen, NémetországNo longer taking part
- University Hospital GreifswaldGreifswald, NémetországNo longer taking part
- UKE HamburgHamburg, NémetországNo longer taking part
- University Hospital HeidelbergHeidelberg, NémetországNo longer taking part
- Universitäres Herzzentrum LübeckLübeck, NémetországNo longer taking part
- Klinikum rechts der IsarMunich, NémetországNo longer taking part
- LMU KlinikumMunich, NémetországNo longer taking part
- LMU Klinikum Standort InnenstadtMünchen, NémetországNo longer taking part
- University Hospital RegensburgRegensburg, NémetországNo longer taking part
Trial details
- Who runs it
- LMU Klinikum
- Trial code
- NCT05570409
- Record updated
- 2025. július 25.
- Original description
Evaluating Immunosuppressive treatment (Mycophenolate mofetil and prednisolon compared to placebo) for 6 months in patients with chronic virus- Negative Inflammatory cardiomyopathy - a multicenter, randomized, double-blind, placebo-controlled trial.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial)
Evaluating Immunosuppressive treatment (Mycophenolate mofetil and prednisolon compared to placebo) for 6 months in patients with chronic virus- Negative Inflammatory cardiomyopathy - a multicenter, randomized, double-blind, placebo-controlled trial.
Inclusion: Age ≥18 years; Medical therapy for HF for ≥3 months and <10 years according to current guideline recommendations; Persistent reduction of LVEF <50% on a 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 child-bearing 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,; Known coronary artery disease responsible for cardiac dysfunction (i.e., prior myocardial infarction, 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.