- Recruiting status
- Recruitment start
- Clinical Trials Registration
Early clinical study
- DZHK Funding
Ulrich Grabmaier, MD
A multicenter, randomized, double-blind, placebo-controlled trial evaluating immunosuppressive treatment in patients with chronic virus-negative inflammatory cardiomyopathy (TRINITY-DZHK26)
Approximately 35% of all patients with heart failure with reduced cardiac function, which does not improve despite intensified heart failure therapy, show a chronic myocardial inflammation ("inflammatory cardiomyopathy", in short: CMPi) as a possible cause in a myocardial biopsy. To date, it has not been adequately investigated whether this type of myocarditis can be treated by taking immunosuppressive therapy and thereby improve heart failure. In order to close this knowledge gap, cardiologists under the lead of the LMU Clinic in Munich have initiated the TRINITY study. In the trial, CMPi confirmed by myocardial biopsy will be contained with the drug mycophenolate mofetil (MMF) in combination with prednisolone. The goal of this time-limited immunosuppressive therapy is to permanently improve cardiac performance and, possibly, prognosis. To better assess the effects and side effects of MMF in combination with prednisolone, this therapy is compared with a placebo therapy. In the multicenter, randomized TRINITY clinical trial, participating patients will be randomly assigned to one of two treatment groups (MMF + prednisolone or placebo). The study participants receive the study medication for a period of six months and are closely monitored by outpatient examinations during this period. This is followed by a six-month follow-up period. A total of 130 patients will be enrolled at 12 specialized centers in Germany.
There are no publications available yet.
Principal investigator: Ulrich Grabmaier (München), Co-PI: Steffen Massberg (München)
Study recruitment is available in these cities
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