Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

Huazhong University of Science and Technology

Status

Enrolling

Conditions

Dilated Cardiomyopathy (DCM)

Treatments

Procedure: Immunoadsorption

Study type

Interventional

Funder types

Other

Identifiers

NCT06922851

PRIA-DCM

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.)