Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06922851

Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-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

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
  • Symptoms of heart failure lasting at least 6 months
  • Receiving guideline-directed medical therapy for at least 6 months with stable doses of ACE inhibitors, ARBs, ARNIs, beta-blockers, SGLT2 inhibitors, MRAs, or sGCa for at least 1 month (excluding diuretics)
  • Hemodynamically stable
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Implantation of implantable cardioverter defibrillator (ICD) less than 1 month ago or cardiac resynchronization therapy (CRT/D) 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 below 90 g/L
  • Any condition requiring immunosuppressive drugs
  • Acute or severe illnesses such as infections, severe liver or kidney dysfunction, blood disorders, cancer, cachexia, autoimmune diseases
  • Previous immunoadsorption or intravenous immunoglobulin therapy
  • Contraindications to extracorporeal circulation like mental illness, consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation problems, multiple organ failure
  • Pregnancy or breastfeeding
  • Other conditions increasing risk or interfering with the study such as severe anxiety, alcohol or drug abuse, cognitive impairment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

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Research Team

X

Xiang Cheng, Professor

CONTACT

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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