A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

NCT ID: NCT02915718

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2023-02-28

Brief Summary

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.

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

Conditions

Dilated Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

protein A immunoadsorption for 5 days

Group Type: EXPERIMENTAL

protein A immunoadsorption

Intervention Type: PROCEDURE

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

control group

non intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

protein A immunoadsorption

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

Intervention Type: PROCEDURE

Other Intervention Names

plasma adsorption

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xiang Cheng

Professor, Chief Physician, Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tian Xie, master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Union Hospital

Wuhan, Hubei, China

Countries

China

References

Ameling S, Herda LR, Hammer E, Steil L, Teumer A, Trimpert C, Dorr M, Kroemer HK, Klingel K, Kandolf R, Volker U, Felix SB. Myocardial gene expression profiles and cardiodepressant autoantibodies predict response of patients with dilated cardiomyopathy to immunoadsorption therapy. Eur Heart J. 2013 Mar;34(9):666-75. doi: 10.1093/eurheartj/ehs330. Epub 2012 Oct 25.

Reference Type: BACKGROUND

PMID: 23100283 (View on PubMed)

Dandel M, Wallukat G, Englert A, Lehmkuhl HB, Knosalla C, Hetzer R. Long-term benefits of immunoadsorption in beta(1)-adrenoceptor autoantibody-positive transplant candidates with dilated cardiomyopathy. Eur J Heart Fail. 2012 Dec;14(12):1374-88. doi: 10.1093/eurjhf/hfs123. Epub 2012 Aug 14.

Reference Type: BACKGROUND

PMID: 22892122 (View on PubMed)

Other Identifiers

XCheng

Identifier Type: -

Identifier Source: org_study_id