Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
60 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria11
- 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.)
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Interventions
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06922851