Treatment for chronic virus-negative inflammatory cardiomyopathy
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial)
This study is testing if a combination of two medications can help people with chronic heart failure caused by inflammation feel better compared to a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 14 sites (Bad Nauheim and 13 other locations) |
| Trial ID | NCT05570409 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of immunosuppressive treatment using Mycophenolate mofetil and prednisolone compared to a placebo in patients with chronic virus-negative inflammatory cardiomyopathy. It is a multicenter, randomized, double-blind, placebo-controlled trial lasting 6 months, focusing on patients with moderate to severe heart failure despite optimal medical treatment. The primary outcome is the absolute increase in left ventricular ejection fraction (LVEF) assessed through MRI at a 12-month follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven virus-negative inflammatory cardiomyopathy and reduced LVEF despite optimal heart failure treatment.
Not a fit: Patients with established cardiotropic virus infections or those who do not meet the specific histopathological criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from inflammatory cardiomyopathy, potentially improving heart function and quality of life.
How similar studies have performed: While existing data on immunosuppression for inflammatory cardiomyopathy is preliminary, this study aims to validate these approaches through a larger randomized trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Medical therapy for HF for ≥3 months and \<10 years according to current guideline recommendations 3. Persistent reduction of LVEF \<50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion 4. 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 5. 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 6. Negative pregnancy test and the use of a highly effective contraceptive measure in women with child-bearing potential (according to CTFG recommendations) 7. Written informed consent. Exclusion Criteria: 1. Histopathological (as approved by the histopathology core lab) and/ or clinical evidence of acute lymphocytic myocarditis, sarcoidosis, GCM or eosinophilic myocarditis, 2. Known systemic inflammatory disease, 3. Recent major surgery within \<6 weeks, recent ICD implantation within \<6 weeks or recent CRT implantation within \<3 months prior to, 4. Known coronary artery disease responsible for cardiac dysfunction (i.e., prior myocardial infarction, persistent stenosis ≥ 70%), 5. Pregnancy or lactation, 6. Contraindications to immunosuppressive treatment with MMF + corticosteroids, 7. Inability to provide informed consent.
Where this trial is running
Bad Nauheim and 13 other locations
- Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (Recruiting)
- Charité - University Hospital Berlin — Berlin, Germany (Recruiting)
- University Hospital Essen — Essen, Germany (Recruiting)
- UHF- Universitäres Herz- und Gefässzentrum — Frankfurt, Germany (Not_yet_recruiting)
- University Hospital Freiburg - Bad Krozingen — Freiburg, Germany (Recruiting)
- University Hospital Greifswald — Greifswald, Germany (Recruiting)
- Universitätsmedizin Göttingen — Göttingen, Germany (Recruiting)
- UKE Hamburg — Hamburg, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Universitäres Herzzentrum Lübeck — Lübeck, Germany (Recruiting)
- Klinikum rechts der Isar — Munich, Germany (Recruiting)
- LMU Klinikum — Munich, Germany (Recruiting)
- LMU Klinikum Standort Innenstadt — München, Germany (Recruiting)
- University Hospital Regensburg — Regensburg, Germany (Recruiting)
Study contacts
- Principal investigator: Urlich Grabmaier, PD Dr. med. — LMU Klinikum
- Study coordinator: Ulrich Grabmaier, PD Dr. med.
- Email: ulrich.grabmaier@med.uni-muenchen.de
- Phone: +49-(0)152-5484-8309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.