Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management in Korean Patients With Uncontrolled Hypertension: A Prospective Non-Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- 24-hour mean systolic blood pressure
研究概览
简要总结
This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Participants are allocated to either a CART BP pro-guided management group or a usual care group based on clinical decision and participant preference. The primary efficacy endpoint is 24-hour mean ambulatory systolic blood pressure at 24 weeks; safety outcomes including treatment-emergent adverse events (TEAEs) are also assessed.
详细描述
Hypertension remains suboptimally controlled despite combination pharmacotherapy, and office blood pressure measurements may not adequately reflect true ambulatory blood pressure burden and nocturnal patterns. CART BP pro is a wearable, cuffless photoplethysmography-based continuous blood pressure monitoring device. This study investigates whether a CART BP pro-guided antihypertensive titration strategy improves 24-hour ambulatory blood pressure control compared with usual care in real-world outpatient settings. Participants receive standard antihypertensive medications (e.g., angiotensin receptor blocker [ARB], calcium channel blocker [CCB], thiazide diuretic) per guideline-based care. In the CART BP pro-guided group, medication adjustments are informed by CART BP pro-derived 24-hour blood pressure data. Follow-up is 24 weeks with optional extended follow-up to 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 19 years
- •Office systolic blood pressure(BP) >= 140 mmHg or diastolic BP >= 90 mmHg
- •Able and willing to provide written informed consent and comply with follow-up visits
排除标准
- •History of intolerance to olmesartan, amlodipine, or hydrochlorothiazide
- •Suspected secondary hypertension
- •Atrial fibrillation
- •Pregnancy or lactation
- •Other serious medical condition that may interfere with study participation
研究组 & 干预措施
CART BP pro-guided management
Participants undergo 24-hour continuous blood pressure monitoring with CART BP pro. Antihypertensive medications are adjusted based on ambulatory blood pressure data.
干预措施: CART BP pro (Device)
Usual care
Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice.
干预措施: Usual care (office BP-based management) (Other)
结局指标
主要结局
24-hour mean systolic blood pressure
时间窗: 24 weeks
Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.
次要结局
- Incidence of treatment-emergent adverse events (TEAE)(24 weeks)
- 24-hour blood pressure load(24 weeks)
- Office blood pressure change(24 weeks)
- Target blood pressure achievement rate(24 weeks)
研究者
Hyung Joon Joo
Professor
Korea University Anam Hospital