A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

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

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).