WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aktiia SA
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change in automated unattended office BP between the two groups from baseline to 6 months
研究概览
简要总结
The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring.
The WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.
详细描述
This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.
There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.
Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.
- Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
- Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.
During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21 to 85 years.
- •Able to read and speak English.
- •Have an MGB provider and medical record number in EPIC
- •Study participants will wear the Aktiia bracelet for 6 months
- •Willing to attend two on-site study visits and comply with all study procedures.
- •Signed informed consent provided.
- •Own a smartphone with iOS or Android operating system.
- •Hypertensive with uncontrolled systolic blood pressure (SBP) >135 mm Hg by unattended automated office measurement
- •Currently taking 0, 1 or 2 antihypertensive medications.
排除标准
- •Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
- •Pregnant or breastfeeding.
- •Known severe heart failure (LVEF < 35%).
- •Known severe valvular heart disease.
- •Known pheochromocytoma.
- •Known severe chronic kidney disease (CKD stage 4-5; eGFR < 30 mL/min/1.73 m²).
- •Known uncontrolled hyperthyroidism or hypothyroidism.
- •Known severe diabetes (Hemoglobin A1c > 10%).
- •Known resting heart rate > 120 bpm.
- •Known persistent atrial fibrillation.
- •Known Raynaud's disease.
- •Known tremors or shivering disorders.
- •Known exfoliative skin diseases.
- •Known allergy to silicone.
- •Presence of lymphedema.
- •Paralysis of the arm.
- •Arm amputation.
- •Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
- •Upper arm circumference < 22 cm or > 42 cm.
- •Wrist circumference > 23 cm.
- •Mastectomy
研究组 & 干预措施
Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
干预措施: Aktiia G1 BP monitor for 12 months (Device)
Group 2: Traditional BP monitor (upper arm cuff) - active control
These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.
干预措施: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months (Device)
结局指标
主要结局
Change in automated unattended office BP between the two groups from baseline to 6 months
时间窗: 6 months
Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.
次要结局
- Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group(6 months)
- Difference in patient engagement and lifestyle features between the 2 groups(0, 6 and 12 months)
- Difference in mean average Aktiia G1 BP measurement after a 6-month period(6 months)