Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Post-treatment average BP for both CardioWatch 287-2 and reference
研究概览
简要总结
Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting during treatment is lacking.
Primary objective: To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs.
Study population: A group, untreated or treated for hypertension, with uncontrolled BP and medical indication for antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs.
Study design: Blood pressure will be measured by the investigative device and a reference device at pre-treatment and after 28 days. The investigative device is the Corsano CardioWatch 287-2, which measures blood pressure through optical photoplethysmography (PPG). The reference method involves automatic blood pressure cuff measurements.
Main study parameters/endpoints: Absolute systolic and diastolic blood pressure decrease after change of treatment measured by the Corsano Cardiowatch 287-2 after 28 days, compared to automatic blood pressure cuff measurements.
详细描述
Background and Introduction:
Blood pressure (BP) is a cardiovascular risk factor that affects millions of people worldwide. BP is a major determinant of stroke, heart failure, coronary artery disease, and chronic kidney disease [1]. Hypertension may be asymptomatic or episodic. Accurate monitoring of BP is required to tailor medication to the patient's specific needs to maintain blood pressure control [2]. Therefore, accurate and continuous monitoring of BP is crucial for optimal diagnosis, treatment, and prevention of cardiovascular events.
However, conventional methods for measuring BP have several limitations. Most BP monitors use an occluding cuff that inflates periodically to obtain intermittent readings. Cuff measurements may not reflect the true BP variations that occur throughout the day and night due to various factors such as physical activity, stress level or sleep quality [3].
Wearable devices are emerging as a promising alternative to conventional methods for measuring BP [4, 5, 6]. They can measure BP continuously and non-invasively by using novel sensors and algorithms that do not require a cuff or electrodes. Wearable devices can also enable remote monitoring and data transmission to healthcare providers or researchers. However, wearable devices need to be evaluated against standard methods in different clinical settings and patient populations.
The Corsano CardioWatch 287-1 conforms with the European Medical Device Regulation (CE-MDR) and is a clinically validated vital signs monitoring bracelet. It is able to continuously measure pulse rate [6], inter-beat intervals [6], breathing rate [7], sleep and activity. The Corsano CardioWatch 287-2, an iteration on the 287-1, adds electrocardiogram (ECG), oxygen saturation (SpO2), galvanic skin response (GSR), core body temperature and non-invasive blood pressure (NIBP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 80 years old;
- •able to provide consent;
- •untreated or treated for hypertension, with uncontrolled BP and medical indication for antihypertensive drug initiation or uptitration or change in antihypertensive drug per doctor prescription.
排除标准
- •Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- •Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- •Pregnant women;
- •Breastfeeding women;
- •Upper arm circumference not within the cuff range (22-42 cm)
- •Unable or not willing to sign for informed consent;
- •Significant mental or cognitive impairment.
研究组 & 干预措施
Patients receiving blood pressure lowering medication (uptitration) as standard of care
Patients receiving blood pressure lowering medication (uptitration) as standard of care
干预措施: Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring (Device)
结局指标
主要结局
Post-treatment average BP for both CardioWatch 287-2 and reference
时间窗: Measured in each patient on 28th/last study day
Post-treatment average blood pressure and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately.
Average BP change comparing CardioWatch 287-2 and reference
时间窗: Measured in each patient on 28th/last study day
Absolute systolic and diastolic BP decrease and its standard deviation after change of treatment measured by the Corsano CardioWatch 287-2 after 28 days of monitoring, compared to automatic blood pressure cuff measurements.
Baseline average BP for both CardioWatch 287-2 and reference
时间窗: Measured in each patient on 1st study day
Baseline average blood pressure per patient and its standard deviation measured by automatic blood pressure cuff reference device and CardioWatch 287-2, separately.
次要结局
- Bland-Altman for CardioWatch 287-2 vs. reference BP(Measured in each patient on 28th/last study day)
- Pearson correlation coefficient between CardioWatch 287-2 vs. reference BP(Measured in each patient on 28th/last study day)