TIMIC
Tailored IMmunosuppression in virus-negative Inflammatory Cardiomyopathy
Doente / População Intervenção / Exposição Comparação Desfecho
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
Desenho
Double-blind, placebo-controlled RCT with baseline and 6-month endomyocardial biopsy
Desfecho
Improvement in left ventricular function at 6 months
Relevância
3
ResultadoLVEF 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
Discussão e crítica
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.