NCT06922851 Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
| NCT ID | NCT06922851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Dilated Cardiomyopathy (DCM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.)
Contact & Investigator
Xiang Cheng, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06922851 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Dilated Cardiomyopathy (DCM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06922851 currently recruiting?
Yes, NCT06922851 is actively recruiting participants. Contact the research team at nathancx@hust.edu.cn for enrollment information.
Where is the NCT06922851 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06922851 clinical trial?
NCT06922851 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Xiang Cheng, M.D., Ph.D. at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 60 participants.