BridgeMD
A multicenter, randomized, double-blind, placebo-controlled TRial evaluating Immunosuppressive treatment in patients with chronic virus-Negative Inflammatory cardiomyopaThY (TRINITY trial)
EU CTIS ID: 2024-512451-20-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Histopathological (as approved by the histopathology core lab) and/ or clinical evidence of acute lymphocytic myocarditis, sarcoidosis, GCM or eosinophilic myocarditis
- Known systemic inflammatory disease
- 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%)
- Pregnancy or lactation
- Contraindications to immunosuppressive treatment with MMF + corticosteroids
See the full eligibility criteria
- 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
- Histopathological (as approved by the histopathology core lab) and/ or clinical evidence of acute lymphocytic myocarditis, sarcoidosis, GCM or eosinophilic myocarditis
- Known systemic inflammatory disease
- 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%)
- Pregnancy or lactation
- Contraindications to immunosuppressive treatment with MMF + corticosteroids
- Inability to provide informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.