Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy
NCT ID: NCT05570409
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
9 participants
INTERVENTIONAL
2023-03-28
2025-04-14
Brief Summary
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Detailed Description
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Patients with biopsy-proven virus-negative inflammatory dilated or non-dilated left ventricular 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Immunosuppressive treatment
Mycophenolate mofetil (MMF) 1g bid and prednisolone at initially 1mg/kg in a step-down regime
Mycophenolate Mofetil
Mycophenolate mofetil 1g bid for 6 months
Prednisolone
initially 1mg/kg in a step-down regime for 6 months
Placebo
Mycophenolate mofetil (MMF) and prednisolone Placebo
Mycophenolate Mofetil Placebo
MMF matching Placebo
Prednisolone Placebo
Prednisolone matching placebo
Interventions
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Mycophenolate Mofetil
Mycophenolate mofetil 1g bid for 6 months
Prednisolone
initially 1mg/kg in a step-down regime for 6 months
Mycophenolate Mofetil Placebo
MMF matching Placebo
Prednisolone Placebo
Prednisolone matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
Technical University of Munich
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital, Essen
OTHER
University Hospital Erlangen
OTHER
University Hospital Tuebingen
OTHER
LMU Klinikum
OTHER
Responsible Party
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Steffen Massberg
Prof. Dr. med.
Principal Investigators
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Steffen Massberg, Prof Dr. med.
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum
Locations
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Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Charité - University Hospital Berlin
Berlin, , Germany
University Hospital Essen
Essen, , Germany
UHF- Universitäres Herz- und Gefässzentrum
Frankfurt, , Germany
University Hospital Freiburg - Bad Krozingen
Freiburg im Breisgau, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
University Hospital Greifswald
Greifswald, , Germany
UKE Hamburg
Hamburg, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Universitäres Herzzentrum Lübeck
Lübeck, , Germany
Klinikum rechts der Isar
Munich, , Germany
LMU Klinikum
Munich, , Germany
LMU Klinikum Standort Innenstadt
München, , Germany
University Hospital Regensburg
Regensburg, , Germany
Countries
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Related Links
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Other Identifiers
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TRINITY
Identifier Type: -
Identifier Source: org_study_id
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