| Title | Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study. | | Author(s) | Frustaci A, Russo MA, Chimenti C | | Institution | Cardiovascular and Respiratory Sciences Department, La Sapienza University, Viale del Policlinico 155, 00161 Rome, Italy. | | Source | Eur Heart J 2009 Jun 25. | | 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19556262 |
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