Status:
RECRUITING
Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Dilated Cardiomyopathy (DCM)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- ICD implantation \< 1 month or CRT/D implantation \< 6 months
- Heart failure caused by other heart diseases
- End-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs
- Expected survival \< 1 year
- Hemoglobin \< 90g/L
- Any disease requiring immunosuppressive drugs
- Commodities with other acute or severe illnesses, such as infections, severe hepatic or renal dysfunction, hematological diseases, malignant tumors, cachexia, autoimmune diseases, etc.
- Previous treatment with immunoadsorption therapy or intravenous immunoglobulin therapy
- Contraindications to extracorporeal circulation therapy, such as mental illness or consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation dysfunction, multiple organ failure, etc.
- Pregnancy/lactation
- Any other conditions that the researcher deems may increase the risk to the subject or interfere with the clinical trial and outcome assessment (such as excessive anxiety, alcohol or drug abuse, or cognitive impairment, etc.)
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06922851
Start Date
June 4 2025
End Date
June 30 2028
Last Update
June 4 2025
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022