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)

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.

Inclusion Criteria:

• 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 Criteria:

• 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.)