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Immunosuppressive Treatment in Chronic Virus-Negative Inflammatory Cardiomyopathy

NCT05570409 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

DRUG

Mycophenolate Mofetil

Mycophenolate mofetil 1g bid for 6 months

DRUG

Prednisolone

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

DRUG

Mycophenolate Mofetil Placebo

MMF matching Placebo

DRUG

Prednisolone Placebo

Prednisolone matching placebo

Sponsors & Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Hospital, Essen

    collaborator OTHER

  • University Hospital Erlangen

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • LMU Klinikum

    lead OTHER

Principal Investigators

  • Steffen Massberg, Prof Dr. med. · LMU Klinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2025-04-14
Completion
2025-04-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570409 on ClinicalTrials.gov