Estimation of apheresis mechanism against heart failure

本研究新发现了一些抗肌动蛋白或Kv1.4通道的自身抗体。这些抗体通过与心肌细胞的Fc和Fab部分的结合被证明具有直接的负性变力作用。血浆肉碱浓度越高的患者出现抗心肌自身抗体的频率越高。这项临床研究自2012年12月起被NHLW批准为“高级医学B”，并支持上述转化性研究。预计这些结果将导致对日本已完成的多中心临床试验做出不适当的PMDA判断。

Some anti-myocardial autoantibodies against titin or Kv1.4 channel were newly detected in this study. These antibodies were proved to have direct negative inotropic effects via attachment between cardiomyocyte and Fc and Fab portion of those IgG. Also some patients with higher plasma concentration of carnitine had more frequently some anti-myocardial autoantibodies. This clinical study was approved as "Advanced medical B" by NHLW from December 2012, and supported above translational studies. Those results are expected to induce not inappropriate PMDA judgment against the completed multi-center clinical trial in Japan.