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.
Dilated cardiomyopathy
Presence of anti-β1-adrenergic receptor
Age 18-75 years
LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)
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
Parallel
Immunoadsorption
Procedure/SurgeryImmunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
Change in LVEF from baseline to 6 months determined by echocardiography
LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months
LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months
NYHA classification at baseline and after 3, 6, 12 and 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.
Safety outcome
The occurrence of adverse events (AE) and serious adverse events (SAE)
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.
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