Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy

NCT05570409 | Terminated Phase 2 DMC

• 1 other identifier: TRINITY
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Inflammatory Cardiomyopathy

Keywords

inflammatory cardiomyopathy; heart failure; Mycophenolate mofetil; chronic myocarditis; myocarditis; enomyocardial biopsy; immunosupression

Outcome Measures

Primary Outcomes (2)

• LVEF increase (metric)

  Absolute increase in LVEF at 12 months follow-up as assessed by blinded investigators of the MRI core lab (metric endpoint)lab) of immunosuppressive treatment with MMF and prednisolone compared to placebo

  12 months follow-up

• LVEF increase (binary)

  Proportion of patients with an absolute increase in LVEF ≥10% at 12 months follow-up as assessed by blinded investigators of the MRI core lab (binary endpoint).

  12 months follow-up

Secondary Outcomes (15)

• Composite clinical outcome

  12 months

• LVEF increase 6 months (MRI)

  6 months follow-up

• Ventricular remodelling (MRI)

  6 and 12 months follow-up

• Strain (MRI)

  6 and 12 months follow-up

• LVEF increase (echo)

  6 and 12 months follow-up

Study Arms (2)

Immunosuppressive treatment

EXPERIMENTAL

Mycophenolate mofetil (MMF) 1g bid and prednisolone at initially 1mg/kg in a step-down regime

Drug: Mycophenolate Mofetil; Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Mycophenolate mofetil (MMF) and prednisolone Placebo

Drug: Mycophenolate Mofetil Placebo; Drug: Prednisolone Placebo

Interventions

Mycophenolate Mofetil DRUG

Mycophenolate mofetil 1g bid for 6 months

Also known as: MMF

Immunosuppressive treatment

Prednisolone DRUG

initially 1mg/kg in a step-down regime for 6 months

Immunosuppressive treatment

Mycophenolate Mofetil Placebo DRUG

MMF matching Placebo

Also known as: MMF Placebo

Placebo

Prednisolone Placebo DRUG

Prednisolone matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Medical therapy for HF for ≥3 months and \<10 years according to current guideline recommendations
• 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.

You may not qualify 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,
• Known coronary artery disease responsible for cardiac dysfunction (i.e., prior myocardial infarction, persistent stenosis ≥ 70%),
• Pregnancy or lactation,
• Contraindications to immunosuppressive treatment with MMF + corticosteroids,
• Inability to provide informed consent.

Sponsors & Collaborators

• LMU Klinikum: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Technical University of Munich: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital, Essen: collaborator
• University Hospital Erlangen: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (14)

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Location

Charité - University Hospital Berlin

Berlin, Germany

Location

University Hospital Essen

Essen, Germany

Location

UHF- Universitäres Herz- und Gefässzentrum

Frankfurt, 60590, Germany

Location

University Hospital Freiburg - Bad Krozingen

Freiburg im Breisgau, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37035, Germany

Location

University Hospital Greifswald

Greifswald, Germany

Location

UKE Hamburg

Hamburg, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Universitäres Herzzentrum Lübeck

Lübeck, 23538, Germany

Location

Klinikum rechts der Isar

Munich, Germany

Location

LMU Klinikum

Munich, Germany

Location

LMU Klinikum Standort Innenstadt

München, 80336, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Related Links

• study website
• sponsor website

MeSH Terms

Conditions

Heart Failure; Myocarditis

Interventions

Mycophenolic Acid; Prednisolone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomyopathies

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Steffen Massberg, Prof Dr. med.

  LMU Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Investigator-initiated, multicenter, randomized, double-blind, placebocontrolled clinical trial

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 6, 2022
• Study Start: March 28, 2023
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14)