Dilated Cardiomyopathy Clinical Trial
Official title:
A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third most common cause of heart failure and the most frequent reason for heart transplantation. The etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of literature suggesting that the humoral immune system activation and autoantibodies against myocardial generation play an important role in the progression of DCM. At present immunoadsorption technology has been successfully applied in autoimmune antibody removal treatment of a variety of diseases. And some applications of immunoadsorption(IA) in patients with DCM showed that immunoadsorption(IA) can indeed reduce the autoantibodies, improve symptoms and prognosis, but additional research is needed to identify indications and instruments for the IA treatment of DCM.
40 patients randomly divided into 2 groups： experimental group and control group
experimental group：
Device: protein A immunoadsorption
protein-A immunoadsorption for 5 days and i.v.(intravenous injection) IgG(Immunoglobulin
G）（0.5g/kg Body weight） substitution
control group：
non intervention
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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