Protein A immunoadsorption for dilated cardiomyopathy with anti–β1-adrenergic receptor antibodies
Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
This trial tests whether Protein A immunoadsorption can improve heart function and outcomes in adults with dilated cardiomyopathy who have anti–β1-adrenergic receptor antibodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06922851 on ClinicalTrials.gov |
What this trial studies
This is a randomized, dual-arm trial enrolling 60 patients with dilated cardiomyopathy and positive anti–β1-adrenergic receptor antibodies who are randomized 1:1 to receive Protein A immunoadsorption or standard care. Participants meet criteria including LVEF ≤40%, NYHA class II–IV, symptoms for ≥6 months, and at least six months of guideline-directed medical therapy with stable doses. The study will follow changes in cardiac function, heart structure, and clinical outcomes over time. Outcomes in the immunoadsorption group will be compared with the control group to determine potential benefit.
Who should consider this trial
Good fit: Adults 18–75 years old with dilated cardiomyopathy, LVEF ≤40%, NYHA class II–IV, positive anti–β1-adrenergic receptor antibodies, hemodynamically stable, and on stable guideline-directed medical therapy are the intended participants.
Not a fit: Patients without anti–β1-adrenergic receptor antibodies, those with end-stage or hemodynamically unstable heart failure, recent device implantation within exclusion windows, severe comorbidities, or contraindications to immunoadsorption are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could reduce pathogenic autoantibodies and lead to improved cardiac function, symptoms, and clinical outcomes for this subgroup of DCM patients.
How similar studies have performed: Smaller and nonrandomized studies of immunoadsorption in antibody-positive DCM have reported symptomatic and functional improvements, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xiang Cheng, M.D., Ph.D. — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Xiang Cheng, Professor
- Email: nathancx@hust.edu.cn
- Phone: +86-18107265338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.