Clinical Trial: A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Brief Summary: 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.

Detailed Summary:

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


Sponsor: Wuhan Union Hospital, China

Current Primary Outcome: Left ventricular ejection fraction (LVEF) at rest [ Time Frame: six months ]

determined by contrast echocardiography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • LVEF at rest [ Time Frame: 1 year ]
    determined by contrast echocardiography
  • Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP) [ Time Frame: 6 months ]


Original Secondary Outcome:

  • LVEF at rest [ Time Frame: 1 year ]
    determined by contrast echocardiography
  • Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [ Time Frame: 6 months ]


Information By: Wuhan Union Hospital, China

Dates:
Date Received: September 20, 2016
Date Started: October 2016
Date Completion: February 2018
Last Updated: October 8, 2016
Last Verified: October 2016