Protein A immunoadsorption for dilated cardiomyopathy with anti–β1-adrenergic receptor antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.