Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: The TIMIC study
Frustaci A et al. – Data confirm the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Lack of response in 12% of cases suggests presence of un-screened viruses or mechanisms of damage and inflammation not susceptible to immunosuppression. Methods- Randomized, double-blind, placebo-controlled study of the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy
- Subjects: 85 pts with myocarditis and chronic (>6 mo) heart failure unresponsive to conventional therapy, with no evidence of myocardial viral genomes
- Administration of either prednisone or placebo, plus conventional therapy for heart failure
- Group 1 (43 pts): prednisone 1 mg kg–1 day–1 for 4 wks; then 0.33 mg kg–1 day–1 for 5 mo and azathioprine 2 mg kg–1 day–1 for 6 mo
- Group 2 (42 pts): placebo
- Primary outcome: 6 mo improvement in left-ventricular function
Results- Group 1: significant improvement of left-ventricular ejection fraction and significant decrease in left-ventricular dimensions and volumes vs baseline
- Group 2: no improvement of ejection fraction; significantly worsened vs baseline
- No major adverse reaction due to immunosuppression
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