A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Huazhong University of Science and Technology

Status

Completed

Conditions

Dilated Cardiomyopathy

Treatments

Procedure: protein A immunoadsorption

Study type

Interventional

Funder types

Other

Identifiers

NCT02915718

XCheng

Details and patient eligibility

About

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.

Full 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

Enrollment

7 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).