Dilated Cardiomyopathy (DCM)
Conditions
Brief summary
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.
Interventions
PROCEDUREImmunoadsorption
Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LVEF from baseline to 6 months determined by echocardiography | From enrollment to follow-up at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | From enrollment to follow-up at 24 months | KCCQ score is scaled from 0 to 100 and higher scores mean better health status. |
| NT-proBNP at baseline and after 3, 6, 12 and 24 months | From enrollment to follow-up at 24 months | — |
| LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months | From enrollment to follow-up at 24 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome | From enrollment to follow-up at 24 months | The occurrence of adverse events (AE) and serious adverse events (SAE) |
| Exploratory outcome and analyses | From enrollment to follow-up at 24 months | 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. |
Countries
China
Contacts
Primary ContactXiang Cheng, Professor
Outcome results
None listed