Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
Recruiting now · Not applicable
Conditions studied: Dilated Cardiomyopathy (DCM)
In brief
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.
Key facts
- Study ID
- NCT06922851
- Run by
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- People needed
- 60
- Starts
- 2025-06-04
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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