Randomized, Prospective Investigation on the Effects of Immunoadsorption on Pulmonary Vascular Resistance in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- pulmonary vascular Resistance
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 haemodynamics in patients with pulmonary hypertension.
详细描述
Increased pulmonary precapillary vascular resistance due to vasoconstriction and vasoproliferative processes is the basic pathophysiological mechanism in the development of pulmonary hypertension (PH). In patients with pulmonary arterial hypertension (PH) production of endothelin-1 (ET-1) is increased and elevated ET-1 plasma levels correlate with PH severity As recently shown Autoantibodies against the Endothelin-1 Typ A and Angiotensin II Typ-1 Receptor, which have a high Incidence in PH-Patients, may also play an important role in the pathophysiology of PH (Dandel et al.).
The concept of this study is that the elimination of these autoantibodies by Immunoadsorption with protein A may improve haemodynamics and patient wellbeing. Immunoglobulins are substituted after Immunoadsorption to minimize infection risk.
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
- •pulmonary hypertension (PH)
- •NYHA II-IV
- •medical treatment of PH respective to current guidelines
- •18 years or older
- •written informed consent of the patient
排除标准
- •pulmonary hypertension due to left ventricular dysfunction
- •decompensated heart failure
- •need for Catecholamines
- •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
pulmonary vascular Resistance
时间窗: 3 month
The extend of change of pulmonary vascular resistance over the observation period will be compared between the 2 groups (treatment versus control group).
次要结局
- electrocardiographic parameters: S´lat. TR Annulus(3 month)
- nt pro BNP(3 month)
- 6 min walktest(3 month)
- peak oxygen uptake (spiroergometry)(3 month)
- ET-1 TYP A Receptor Autoantibody level(3 month)
- echocardiographic parameters: TAPSE(3 month)
- NYHA(3 month)
- echocardiographic parameters: PAPs(3 month)
- echocardiographic parameters: AT right ventricular outflow(3 month)
研究者
Marcus Doerr
MD
University Medicine Greifswald