Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy — TRINITY  

Inflammatory Cardiomyopathy Clinical Trial

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Inflammatory cardiomyopathy constitutes a relevant part of the cohort of hypokinetic non-dilated cardiomyopathy (HNDC)/ dilated cardiomyopathy (DCM) and is associated with adverse outcome. Urgent medical needs remain with respect to the therapeutic options for inflammatory cardiomyopathy. So far, no specific therapy for patients with inflammatory cardiomyopathy is available. Existing data on immunosuppression for inflammatory cardiomyopathy is preliminary and needs further validation by larger randomized, controlled, multicenter trials.

Patients with biopsy-proven virus-negative inflammatory dilated or hypokinetic non-dilated cardiomyopathy and moderate to severe deterioration of cardiac function despite optimal medical treatment (OMT) for heart failure (HF) will be randomized (1:1) in a double-blinded way to Mycophenolate mofetil (MMF) 1g bid and prednisolone at initially 1mg/kg in a step-down regime for 6 months or placebo. The clinical benefit will be measured 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. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Inflammatory Cardiomyopathy

• NCT number: NCT05570409
• Study type: Interventional
• Source: LMU Klinikum
• Contact: Ulrich Grabmaier, PD Dr. med.
• Phone: +49-(0)152-5484-8309
• Email: ulrich.grabmaier@med.uni-muenchen.de
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 28, 2023
• Completion date: March 28, 2028