Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
NCT ID: NCT06922851
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-06-04
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immuoadsorption group
receiving immunoadsorption therapy
Immunoadsorption
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Control group
not receiving immunoadsorption therapy
No interventions assigned to this group
Interventions
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Immunoadsorption
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
75 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Xiang Cheng
Professor
Principal Investigators
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Xiang Cheng, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRIA-DCM
Identifier Type: -
Identifier Source: org_study_id
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