Clinical trial NCT06922851: Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
Official title: Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dilated Cardiomyopathy (DCM)
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Change in LVEF from baseline to 6 months determined by echocardiography
timeFrame: From enrollment to follow-up at 6 months
Secondary outcomes:
measure: LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months
timeFrame: From enrollment to follow-up at 24 months
measure: LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months
timeFrame: From enrollment to follow-up at 24 months
measure: NYHA classification at baseline and after 3, 6, 12 and 24 months
timeFrame: From enrollment to follow-up at 24 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months
timeFrame: From enrollment to follow-up at 24 months
measure: NT-proBNP at baseline and after 3, 6, 12 and 24 months
timeFrame: From enrollment to follow-up at 24 months
Other outcomes:
measure: Safety outcome
timeFrame: From enrollment to follow-up at 24 months
measure: Exploratory outcome and analyses
timeFrame: From enrollment to follow-up at 24 months
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiang Cheng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: