Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dilated Cardiomyopathy (DCM)
• Intervention / Treatment: Procedure: Immunoadsorption

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Cheng, Professor; Phone Number: +86-18107265338; Email: nathancx@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Tingting Tang; Phone Number: +86-02786726011; Email: nathancx@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immuoadsorption group; receiving immunoadsorption therapy	Procedure: Immunoadsorption; Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA
No Intervention: Control group; not receiving immunoadsorption therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LVEF from baseline to 6 months determined by echocardiography	From enrollment to follow-up at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
NT-proBNP 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	KCCQ score is scaled from 0 to 100 and higher scores mean better health status.	From enrollment to follow-up at 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	The occurrence of adverse events (AE) and serious adverse events (SAE)	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; Changes in serum levels of IgG, IgA, IgM, IgD, IgE and IgG subclasses from baseline to 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; Changes in serum levels of anti-β1-adrenergic receptor from baseline to day 5 and months 3, 6, 12 and 24; Serum levels of autoantibodies at baseline and after 3, 6, 12 and 24 months.	From enrollment to follow-up at 24 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Xiang Cheng, M.D., Ph.D., Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Laminopathies; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Cardiomegaly; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: PRIA-DCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No