TIMIC
Tailored IMmunosuppression in virus-negative Inflammatory Cardiomyopathy
Patient / Population Intervention / Exposure Comparison Outcome
In 85 patients with biopsy-proven virus-negative inflammatory cardiomyopathy and heart failure refractory to conventional therapy, 6 months of prednisone plus azathioprine improved left ventricular ejection fraction at 6 months compared with placebo.
N
85
Design
Double-blind, placebo-controlled RCT with baseline and 6-month endomyocardial biopsy
Endpoint
Improvement in left ventricular function at 6 months
Relevance
3
ResultLVEF rose from 26.5 % to 45.6 % with immunosuppression versus a fall from 27.7 % to 21.3 % on placebo (p<0.001); 88 % of treated patients improved versus none on placebo.
Frustaci A, Russo MA, Chimenti C. Eur Heart J. 2009;30(16):1995-2002. 10.1093/eurheartj/ehp249
Discussion & critique
Single-centre, small, with an echocardiographic surrogate endpoint and no hard outcomes, and the strategy only works where endomyocardial biopsy with viral PCR is routine. It is the only randomised trial showing that immunosuppression reverses virus-negative inflammatory cardiomyopathy and is the direct basis for the biopsy-guided pathway.