A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

April 6, 2025 updated by: Xiang Cheng, Wuhan Union Hospital, China

A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third most common cause of heart failure and the most frequent reason for heart transplantation. The etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of literature suggesting that the humoral immune system activation and autoantibodies against myocardial generation play an important role in the progression of DCM. At present immunoadsorption technology has been successfully applied in autoimmune antibody removal treatment of a variety of diseases. And some applications of immunoadsorption(IA) in patients with DCM showed that immunoadsorption(IA) can indeed reduce the autoantibodies, improve symptoms and prognosis, but additional research is needed to identify indications and instruments for the IA treatment of DCM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

40 patients randomly divided into 2 groups： experimental group and control group

experimental group：

Device: protein A immunoadsorption

protein-A immunoadsorption for 5 days and i.v.(intravenous injection) IgG(Immunoglobulin G）（0.5g/kg Body weight） substitution

control group：

non intervention

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiang Cheng, doctor
  • Phone Number: +8615972150162
  • Email: 715494934@qq.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dilated cardiomyopathy
  • LVEF <= 40% determined by contrast echocardiography
  • NYHA(New York Heart Association) class II - IV
  • Age 18-70
  • Disease duration: symptomatic heart failure ≥ 6 months prior to screening date
  • Treatment with Angiotensin-Converting Enzyme inhibitors(ACEI) or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
  • β1 adrenergic receptor antibody positive
  • The patient's informed consent

Exclusion Criteria:

  • NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
  • Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, ≥50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree
  • History of myocardial infarction
  • Acute myocarditis according to Dallas criteria
  • Endocrine disorder excluding insulin-dependent diabetes mellitus
  • Implanted cardiac defibrillator (ICD) <1 month before screening date
  • Cardiac resynchronization therapy (CRT) <6 months before screening date
  • I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.
  • Active infectious disease, or signs of ongoing infection with C-reactive protein(CRP) >10mmol/L
  • Impaired renal function (serum creatinine >220 µmol/L)
  • Any disease requiring immunosuppressive drugs
  • Anaemia (haemoglobin below 90 g/L) due to other causes than congestive heart failure(CHF)
  • Pregnancy or lactation, or childbearing potential without appropriate contraception
  • Alcohol or drug abuse
  • Presence of a malignant tumour, or remission of malignancy < 5 years
  • Refusal of the patient to provide consent
  • Suspected poor capability to follow instructions and cooperate
  • Another life-threatening disease with poor prognosis (survival less than 2 years)
  • Participation in any other clinical study within less than 30 days prior to screening date
  • Previous treatments with IA or immunoglobulin
  • Contraindications for application of the echocardiography contrast agent used (in accordance to the product specification).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
protein A immunoadsorption for 5 days
Procedure: protein A immunoadsorption
protein-A immunoadsorption for 5 days and i.v. IgG（0.5g/kg Body weight）substitution
Other Names:
  • plasma adsorption
No Intervention: control group
non intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF) at rest
Time Frame: six months
determined by contrast echocardiography
six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LVEF at rest
Time Frame: 1 year
determined by contrast echocardiography
1 year
Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Union Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tian Xie, master, Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XCheng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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