Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

NCT06922851 | Recruiting

• 1 other identifier: PRIA-DCM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Cardiomyopathy (DCM)

Outcome Measures

Primary Outcomes (1)

• Change in LVEF from baseline to 6 months determined by echocardiography

  From enrollment to follow-up at 6 months

Secondary Outcomes (5)

• 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

• 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

• NT-proBNP at baseline and after 3, 6, 12 and 24 months

  From enrollment to follow-up at 24 months

Other Outcomes (2)

• Safety outcome

  From enrollment to follow-up at 24 months

• Exploratory outcome and analyses

  From enrollment to follow-up at 24 months

Study Arms (2)

Immuoadsorption group

EXPERIMENTAL

receiving immunoadsorption therapy

Procedure: Immunoadsorption

Control group

NO INTERVENTION

not receiving immunoadsorption therapy

Interventions

Immunoadsorption PROCEDURE

Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA

Immuoadsorption group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Xiang Cheng, M.D., Ph.D.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Cheng, Professor

CONTACT

+86-18107265338; nathancx@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)