Actively Recruiting
Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-06-04
60
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized controlled clinical trial to study patients with dilated cardiomyopathy who have positive beta-1 adrenergic receptor autoantibodies. The trial aims to evaluate and compare the effects of immunoadsorption therapy on heart function, heart structure, and clinical outcomes. Sixty patients aged 18 to 75 years with specific heart failure symptoms and stable medical treatment are being studied to better understand this potential treatment's impact. Participants are randomly assigned to one of two groups: one receiving immunoadsorption therapy using a protein A column for four consecutive days followed by immunoglobulin supplementation, and a control group that does not receive immunoadsorption therapy. This therapy is studied as a procedure. The study monitors patients for changes in heart function and symptoms over time, specifically following up at 3, 6, 12, and 24 months. During the trial, participants undergo regular assessments including echocardiography to measure heart function and size, symptom classification, questionnaires about their heart failure impact, and blood tests for heart failure markers. The primary outcome is the change in left ventricular ejection fraction (LVEF) at 6 months, with additional outcomes tracked up to 24 months. Researchers also monitor safety and clinical status throughout the study, which lasts up to two years after enrollment.
CONDITIONS
Brief Title
Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of dilated cardiomyopathy
- Presence of anti-beta1-adrenergic receptor autoantibodies
- Age between 18 and 75 years
- Left ventricular ejection fraction (LVEF) of 40% or less by echocardiography
- New York Heart Association (NYHA) class II to IV
- Heart failure symptoms for at least 6 months
- On stable guideline-directed medical therapy for 6 months with stable doses for at least 1 month
- Hemodynamically stable condition
- Ability to provide informed consent
You will not qualify if you...
- ICD implantation less than 1 month ago or CRT/D implantation less than 6 months ago
- Heart failure caused by other heart diseases
- End-stage heart failure requiring continuous intravenous inotropic or vasoactive drugs
- Expected survival less than 1 year
- Hemoglobin less than 90 g/L
- Use of immunosuppressive drugs for other diseases
- Acute or severe illnesses such as infections, severe liver or kidney problems, blood diseases, cancer, cachexia, or autoimmune diseases
- Previous immunoadsorption or intravenous immunoglobulin therapy
- Contraindications to extracorporeal circulation therapy, including mental illness, shock, severe bleeding, coagulation problems, or multiple organ failure
- Pregnancy or breastfeeding
- Any condition that may increase risk or interfere with the trial, such as severe anxiety, substance abuse, or cognitive impairment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 consecutive days
Participants receive immunoadsorption therapy using a protein A column for four consecutive days, followed by immunoglobulin supplementation after immunoadsorption.
4 visits (in-person, daily during treatment)
Duration - Up to 24 months
Participants are monitored with echocardiography and assessments of heart function and symptoms at multiple time points after treatment.
Visits at 3, 6, 12, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
X
Xiang Cheng, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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