Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- HF specific motion sensor characteristics validation against echocardiography and other clinical features
研究概览
简要总结
In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.
详细描述
Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood in circulation corresponding to prevailing physiological demand. Gyrocardiography is a technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope, to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of this study is to test the ability of an app of a smartphone with embedded motion sensors, positioned on the chest which measures the movements and function of the heart, to identify patients with different types of heart failure and their characteristics, as compared with clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac mechanics including strain, cardiac torsion, diastolic filling characteristics.
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
- •Age >18 years
- •Patients visiting hospital for heart failure, either outpatient clinic or cardiac ward
- •Signed informed consent as an acceptance to participate to the trial
排除标准
- •Age <18 years
- •Severe cardiac valve disease
- •Previous prosthetic cardiac valve
- •Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
- •Patients with pacemaker
- •Informed consent form not signed.
结局指标
主要结局
HF specific motion sensor characteristics validation against echocardiography and other clinical features
时间窗: From the hospital admission to study closure visit, on average 15 weeks
The study aims to validate HF specific characteristics obtained with accelerometer (m/s2) and gyroscope (degree/s) against the current gold standard, detailed echocardiography examination in individuals already diagnosed with HF. Data of anonymised subjects without diagnosed or suspected HF will be used as controls to study the detection of HF.
次要结局
- HF decompensation specific motion sensor characteristics validation(14 weeks)