Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- accuracy of 3-dimensional measurements
研究概览
简要总结
The purpose of the study is two-fold:
- to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
- to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.
详细描述
Leg-edema are common in patients with worsening heart failure. Apart from using a measuring tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart failure early detection of leg-edema is quite difficult.
From earlier pacemaker-studies it has been shown that an increase of afterload changes ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring blood-pressure affect QRS-morphology in patients with 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
- 否
入选标准
- •hospitalization for worsening heart failure
- •age greater than 18 years
- •ability to stand without help from others
- •informed consent
排除标准
- •leg-edema of non-cardiac origin (venous, lymphatic)
- •dialysis shunt
结局指标
主要结局
accuracy of 3-dimensional measurements
时间窗: 10 days
the 3-D camera will record changes in leg-shape around the ankles that result from reabsorption of fluid. These changes will be compared with changes in leg-circumference using a measuring tape
次要结局
未报告次要终点