Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: The TIMIC study

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Abstract

Aims: To evaluate the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Methods and results: This randomized, double-blind, placebo-controlled study included 85 patients with myocarditis and chronic (>6 months) heart failure unresponsive to conventional therapy, with no evidence of myocardial viral genomes. Patients received either prednisone 1 mg kg-1 day-1 for 4 weeks followed by 0.33 mg kg-1 day-1 for 5 months and azathioprine 2 mg kg-1 day -1 for 6 months (43 patients, Group 1) or placebo (42 patients, Group 2) in addition to conventional therapy for heart failure. Primary outcome was the 6 month improvement in left-ventricular function. Group 1 showed a significant improvement of left-ventricular ejection fraction and a significant decrease in left-ventricular dimensions and volumes compared with baseline. None of Group 2 patients showed improvement of ejection fraction, that significantly worsened compared with baseline. No major adverse reaction was registered as a result of immunosuppression. Conclusion: These data confirm the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Lack of response in 12% of cases suggests the presence of not screened viruses or mechanisms of damage and inflammation not susceptible to immunosuppression.

Original languageEnglish
Pages (from-to)1995-2002
Number of pages8
JournalEuropean Heart Journal
Volume30
Issue number16
DOIs
Publication statusPublished - Aug 2009

Keywords

  • Ejection fraction
  • Heart failure
  • Immunosuppressive therapy
  • Inflammatory cardiomyopathy
  • NYHA class

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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