Impact of LVAD Implantation on Micro- and Macrovascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Macrovascular function measured by flow-mediated vasodilation (FMD)
研究概览
简要总结
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients after HTX
- •patients after LVAD implantation
- •patients with stable coronary heart disease and normal systolic left ventricular function
- •healthy volunteers
- •written informed consent
排除标准
- •acute inflammation
- •cardiac arrhythmia
- •renal failure
- •malignant disease
结局指标
主要结局
Macrovascular function measured by flow-mediated vasodilation (FMD)
时间窗: 3 months after implantation
次要结局
- microparticles determined by Flow Cytometry(3 months after implantation)
- Microvascular function assessed by non-invasive laser Doppler imaging(3 months after implantation)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Division of Cardiology, Pulmonary Diseases, Vascular Medicine
Heinrich-Heine University, Duesseldorf