Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)

NCT ID: NCT06922851

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dilated Cardiomyopathy (DCM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immuoadsorption group

receiving immunoadsorption therapy

Group Type EXPERIMENTAL

Immunoadsorption

Intervention Type PROCEDURE

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

Control group

not receiving immunoadsorption therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immunoadsorption

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Xiang Cheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiang Cheng, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Cheng, Professor

Role: CONTACT

+86-18107265338

Facility Contacts

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Tingting Tang

Role: primary

+86-02786726011

Other Identifiers

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PRIA-DCM

Identifier Type: -

Identifier Source: org_study_id

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