Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
研究概览
简要总结
Fluid status and congestion can be determined by the CPM wearable device and correlates with invasive measures, non-invasive measures and biochemical markers of congestion and changes in congestion.
详细描述
HF is associated with frequent and lengthy hospitalisations. These hospitalisations are usually as a result of congestion. The signs of congestion that can be recognised by physicians or health care professionals such as lung crackles or worsening of peripheral oedema are often seen at a late stage before an intervention can be made to prevent overt decompensation and admission to hospital. Recognising changes in excess fluid status either before a patient becomes unwell or during decongestion treatment is highly desirable so that timely treatment can be started or so that treatment can be adjusted based on an individual's response to therapy. The ability to assess patients by applying a single, non-invasive device would potentially provide a useful tool for assessing a patient's congestion levels and allow patients with progressive deterioration to be identified earlier.
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
- •Written informed consent
- •Male or female over18 years of age Cohort A
- •Meet European Society of Cardiology 1 (ESC) criteria for diagnosis of HF
- •Undergoing clinically-indicated RHC Cohort B
- •Established on haemodialysis for >90 days
- •Undergoing haemodialysis with target volume removal ≥1.5 litres fluid Cohort C
- •Meet ESC criteria for diagnosis of HF including heart failure
- •Requiring treatment with intravenous (IV) diuretics Training Cohort
- •Meet ESC criteria for diagnosis of HF including heart failure
- •Requiring treatment with intravenous (IV) diuretics
排除标准
- •Unable to consent to inclusion in study due to cognitive impairment
- •Allergies or skin sensitivities to silicone-based adhesive
- •Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed
- •Pregnancy or breast-feeding
- •Conditions that may confound congestion assessments
- •COVID-19 infection.
结局指标
主要结局
Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
时间窗: 4 hours
Cohort B: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and volume of fluid removed by dialysis in mls
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and clinical measures of congestion
时间窗: 24 hours
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and change in weight (kg)
Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure
时间窗: 3 months
Cohort A: determine the correlation between congestion measured by the CPM wearable device and pulmonary capillary wedge pressure measured in mmHg
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS)
时间窗: 24 hours
Cohort C: To determine the correlation between congestion and change in congestion measured by the CPM wearable device and lung ultrasound (LUS) measured as change in number of B lines
次要结局
- Cohort A: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score(3 months)
- Cohort B: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry(24 hours)
- Cohort C: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry(24 hours)
- Cohort C: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score(24 hours)
- Cohort A: To determine the correlation between pulmonary function measured by the CPM wearable device and spirometry(24 hours)
- Cohort A: To determine the correlation between congestion measured by the CPM wearable device and right heart catheter (RHC) measurements(3 months)
- Cohort C: To determine the correlation between congestion measured by the CPM wearable device and echocardiography(24 hours)
- Cohort B: To determine the correlation between congestion measured by the CPM wearable device and the Everest clinical congestions score(4 hours)
- Cohort A: To determine the correlation between congestion measured by the CPM wearable device and echocardiography(3 months)
- Cohort B: To determine the correlation between congestion measured by the CPM wearable device and echocardiography(4 hours)