NCT02915718

A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	protein A immunoadsorption	protein-A immunoadsorption for 5 days and i.v. IgG（0.5g/kg Body weight）substitution

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-02-01
• Completion: 2023-02-01
• First posted: 2016-09-27
• Last updated: 2025-04-09

Locations

1 site across 1 country: China