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NCT Number: NCT06922851

Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

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.

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Key information

Conditions

Dilated Cardiomyopathy (DCM) Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, 430022, China

Location status: Recruiting

Location contact

Tingting Tang

CONTACT

[email protected]

+86-02786726011

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Immunoadsorption

Procedure

Immunoadsorption (IA) therapy using a protein A column for four consecutive days, plus immunoglobulin supplementation after IA

Primary outcomes

  1. Change in LVEF from baseline to 6 months determined by echocardiography

    Time frame: From enrollment to follow-up at 6 months

Secondary outcomes

  1. LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months

    Time frame: From enrollment to follow-up at 24 months

  2. LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months

    Time frame: From enrollment to follow-up at 24 months

  3. NYHA classification at baseline and after 3, 6, 12 and 24 months

    Time frame: From enrollment to follow-up at 24 months

  4. Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months

    Time frame: From enrollment to follow-up at 24 months

    KCCQ score is scaled from 0 to 100 and higher scores mean better health status.

  5. NT-proBNP at baseline and after 3, 6, 12 and 24 months

    Time frame: From enrollment to follow-up at 24 months

Other outcomes

  1. Safety outcome

    Time frame: From enrollment to follow-up at 24 months

    The occurrence of adverse events (AE) and serious adverse events (SAE)

  2. Exploratory outcome and analyses

    Time frame: From enrollment to follow-up at 24 months

    Composite of all-cause mortality, heart transplantation, implantation of LVAD or hospitalization for heart failure at 24 months; Symptom duration; Genetic variants; Serum levels of IgG, IgA, IgM, IgD, IgE and IgG subclasses at baseline, treatment day 1 to 4 (twice every day: before treatment and within 1 h after treatment), day 5 and month 3, 6, 12 and 24; Serum levels of anti-β1-adrenergic receptor at baseline, day 5, months 3, 6, 12 and 24; Serum levels of autoantibodies at baseline and after 3, 6, 12 and 24 months; Cardiac structure, function and fibrosis assessed using cardiac magnetic resonance imaging at baseline and 6-month.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Cheng, Professor

CONTACT

[email protected]

+86-18107265338

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 11, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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