Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- left-ventricular ejection fraction as measured by echocardiography
研究概览
简要总结
The purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.
详细描述
Heart failure due to coronary heart disease (CHD) remains one of the most frequent causes of death. Left-ventricular ejection fraction < 30% is associated with a 5-year mortality > 70%. Therefore, new strategies and therapies towards treatment of heart failure are needed.
Heart failure due to left ventricular dysfunction can develop in CHD beyond the area of myocardial infarction. Some of these patients develop myocardial autoantibodies, which have been shown to exert a negative inotropic effect. Their elimination by immunoadsorption has been shown to improve left ventricular function in dilatative cardiomyopathy. Immunoglobulins are substituted to minimize infection risk at a level, which has been shown not to effect cardiac function. This intervention might also ameliorate cardiac function in patients with heart failure due to other origins. This study therefore aims to evaluate the effect of immunoadsorption with subsequent immunoglobulin substitution.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure and known coronary heart disease / post myocardial infarction
- •completed treatment for coronary heart disease (no known hemodynamically effective stenosis in coronary vessels)
- •evidence of scarred myocardial tissue in low-dose stress echocardiography or myocardial scintigraphy or MRI
- •evidence of hypo-contractile myocardium in echocardiography or MRI outside of infarction area
- •at least 3 months without acute coronary syndrome or coronary intervention
- •left-ventricular ejection fraction by echocardiography < 45%
- •detection of at least one myocardial autoantibody (e.g. anti-ß1-receptor, anti-TnI, anti-KchIP2) in serum
- •dyspnea on exertion equivalent to NYHA II - NYHA IV
- •written informed consent of the patient
排除标准
- •heart failure due to other cardiac disease (e.g. dilatative cardiomyopathy without evidence of CHD, primary valve defects > II°, toxic cardiomyopathy)
- •active infection
- •pregnancy
- •malign tumor disease
- •other secondary disease with life expectancy < 1 year
- •refusal by the patient
结局指标
主要结局
left-ventricular ejection fraction as measured by echocardiography
时间窗: 6 months
次要结局
- cardiac index(6 months)
- systemic vascular resistance(6 months)
- pulmonary vascular resistance(6 months)
- n-terminal pro-BNP concentration (serum)(6 months)
- peak oxygen uptake (spiroergometric)(6 months)
- dyspnoea symptoms / NYHA classification(6 months)