Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study.
OBJECTIVE
To evaluate the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy.


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.


CONCLUSIONS
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.
Frustaci
Andrea
A
Cardiovascular and Respiratory Sciences Department, La Sapienza University, Viale del Policlinico 155, Rome 00161, Italy. biocard@inmi.it
Russo
Matteo A
MA
Chimenti
Cristina
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008875:Middle Aged; D009205:Myocarditis / Q000188:drug therapy* / Q000503:physiopathology; D013318:Stroke Volume; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000209:etiology / Q000503:physiopathology; D055815:Young Adult
D007166:Immunosuppressive Agents; D001379:Azathioprine