A Randomized, Open, Controlled Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (LVEF) at rest
研究概览
简要总结
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.
详细描述
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：
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Left ventricular ejection fraction (LVEF) at rest
时间窗: six months
determined by contrast echocardiography
次要结局
- LVEF at rest(1 year)
- Reduction of brain natriuretic peptides (BNP) or N-terminal pro-Brain Natriuretic Peptide(NT pro-BNP)(6 months)
研究者
Xiang Cheng
Professor, Chief Physician, Deputy Director
Wuhan Union Hospital, China