Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Apr 3, 2025

Keywords

ClinConnect Summary

The RPIA-DCM clinical trial is studying a treatment called immunoadsorption for patients with dilated cardiomyopathy (DCM), a condition where the heart becomes enlarged and weakened, making it hard for it to pump blood effectively. In this study, 60 participants will be randomly assigned to either receive immunoadsorption therapy, which aims to remove harmful antibodies from the bloodstream, or be in a control group that does not receive this treatment. Researchers will monitor changes in heart function and overall health over time to see if the therapy helps improve their condition.

To be eligible for this trial, participants should be between 18 and 75 years old and have a diagnosis of dilated cardiomyopathy with specific heart issues (like a low heart function score). They should have been experiencing heart failure symptoms for at least six months and have been on stable heart medication for at least a month. However, there are several criteria that could disqualify someone from participating, such as recent heart device implantation or other serious health issues. If eligible, participants can expect regular check-ups and care throughout the study, and their contribution could help advance treatment options for others with DCM.

Gender

ALL

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.)