RECRUITINGINTERVENTIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
- willing to sign a consent form
Who Should NOT Join This Trial:
- 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 conditions (where your immune system attacks your own body)s, 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.)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.)
Treatments Being Tested
PROCEDURE
Immunoadsorption
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Locations (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China