Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Changes in cardiac function, morphology and clinical outcomes were followed up and compared.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Dilated cardiomyopathy

• Presence of anti-β1-adrenergic receptor

• Age 18-75 years

• LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)

• NYHA class II-IV

• Symptoms of heart failure ≥ 6 months

• Treatment with guideline-directed medical therapy (GDMT) for ≥6 months and stable dose of ACEI/ARB/ARNI/β-blocker/SGLT2i/MRA/sGCa for ≥1 month (excluding diuretics)

• Hemodynamically stable

• Informed consent

Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiang Cheng, Professor
nathancx@hust.edu.cn
+86-18107265338
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Immuoadsorption group
receiving immunoadsorption therapy
No_intervention: Control group
not receiving immunoadsorption therapy
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov