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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuoadsorption group | Experimental | receiving immunoadsorption therapy |
|
| Control group | No Intervention | not receiving immunoadsorption therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoadsorption | Procedure | Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVEF from baseline to 6 months determined by echocardiography | From enrollment to follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months | From enrollment to follow-up at 24 months | |
| LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months | From enrollment to follow-up at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | The occurrence of adverse events (AE) and serious adverse events (SAE) | From enrollment to follow-up at 24 months |
| Exploratory outcome and analyses | Composite of all-cause mortality, heart transplantation, implantation of LVAD or hospitalization for heart failure at 24 months; Symptom duration; Genetic variants; Serum levels of IgG, IgA, IgM, IgD, IgE and IgG subclasses at baseline, treatment day 1 to 4 (twice every day: before treatment and within 1 h after treatment), day 5 and month 3, 6, 12 and 24; Serum levels of anti-β1-adrenergic receptor at baseline, day 5, months 3, 6, 12 and 24; Serum levels of autoantibodies at baseline and after 3, 6, 12 and 24 months; Cardiac structure, function and fibrosis assessed using cardiac magnetic resonance imaging at baseline and 6-month. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Cheng, Professor | Contact | +86-18107265338 | nathancx@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Cheng, M.D., Ph.D. | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| NYHA classification at baseline and after 3, 6, 12 and 24 months | From enrollment to follow-up at 24 months |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months | KCCQ score is scaled from 0 to 100 and higher scores mean better health status. | From enrollment to follow-up at 24 months |
| NT-proBNP at baseline and after 3, 6, 12 and 24 months | From enrollment to follow-up at 24 months |
| From enrollment to follow-up at 24 months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013514 | Surgical Procedures, Operative |