An interventional study of Immunoadsorption in Dilated Cardiomyopathy (DCM), sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Wuhan Union Hospital, China · Not applicable, Interventional, and Treatment
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receiving immunoadsorption therapy
Procedure: Immunoadsorption
not receiving immunoadsorption therapy
Immunoadsorption (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
Time frame: From enrollment to follow-up at 6 months
LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months
Time frame: 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
Time frame: From enrollment to follow-up at 24 months
NYHA classification at baseline and after 3, 6, 12 and 24 months
Time frame: 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.
Time frame: From enrollment to follow-up at 24 months
NT-proBNP at baseline and after 3, 6, 12 and 24 months
Time frame: From enrollment to follow-up at 24 months
Safety outcome
The occurrence of adverse events (AE) and serious adverse events (SAE)
Time frame: 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.
Time frame: From enrollment to follow-up at 24 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wuhan Union Hospital, China