Wearable Ambulatory Versus Office Blood Pressure-Guided Hypertension Management in Hemodialysis Patients: A Multicenter, Single-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Achievement of target out-of-office blood pressure
研究概览
简要总结
Hypertension is highly prevalent among patients receiving maintenance hemodialysis and is associated with increased cardiovascular morbidity and mortality. Accurate blood pressure assessment is essential for optimizing dry weight and antihypertensive therapy, but conventional office blood pressure measurements may not adequately capture the dynamic blood pressure variations that occur throughout the hemodialysis cycle, including the pre-, intra-, post-, and interdialytic periods. Wearable cuffless blood pressure monitoring may provide more comprehensive blood pressure data and facilitate individualized blood pressure management.
The WAVE-HD trial is a prospective, multicenter, single-blind, randomized controlled study designed to compare wearable blood pressure-guided hypertension management using the CART BP Pro device with conventional office blood pressure-guided management in adult patients receiving maintenance hemodialysis. Participants will be randomized in a 1:1 ratio to either the wearable blood pressure-guided management group or the office blood pressure-guided management group. Dry weight and antihypertensive medications will be adjusted according to the assigned blood pressure monitoring strategy. The primary objective of the study is to determine whether wearable blood pressure-guided management increases the proportion of patients achieving target blood pressure compared with conventional office blood pressure-guided management. Secondary outcomes include changes in blood pressure, blood pressure variability, dry weight, antihypertensive medication use, and safety.
详细描述
Design: Prospective, randomized, single-blind, controlled clinical trial
Study duration: Total of 11 weeks after participant enrollment
- Screening: 1 week
- Baseline: Week 0
- Intervention: Weeks 1-9
- Evaluation: Weeks 10-11
Sample size: A total of 280 participants (140 in the intervention group vs. 140 in the control group)
Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation throughout the study. Both groups will wear the CART BP Pro device, and participants will not be informed whether blood pressure management is guided by wearable blood pressure monitoring or conventional office blood pressure measurements. Allocation concealment will be maintained using sequentially numbered, sealed envelopes prepared according to a computer-generated block randomization schedule. Treating investigators responsible for dry weight and antihypertensive medication adjustment will not be blinded to group assignment. Statistical analyses will be performed by statisticians who remain blinded to treatment allocation until completion of the primary analysis.
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
- •Adults aged 19 years or older.
- •Patients receiving hemodialysis three times per week.
- •On maintenance hemodialysis for at least 3 months.
- •Patients with a predialysis blood pressure (BP) of ≥140/90 mmHg measured in the dialysis clinic before study enrollment, or those taking at least one antihypertensive medication.
- •Individuals who provided informed consent to participate in the study.
排除标准
- •Presence of an implanted cardiac pacemaker.
- •Patients in whom pulse wave measurement is not feasible due to uncontrolled arrhythmias (e.g., persistent atrial fibrillation).
- •Inability to wear the CART BP Pro device (e.g., due to finger deformity).
- •Life expectancy of less than 6 months.
研究组 & 干预措施
Wearable blood pressure-guided management
Participants will undergo wearable blood pressure monitoring using the CART BP Pro device. Dry weight and antihypertensive medications will be adjusted according to wearable blood pressure measurements throughout the study.
干预措施: CART BP Pro-guided blood pressure management (Device)
Conventional office blood pressure-guided management
Participants will undergo wearable blood pressure monitoring using the CART BP Pro device. However, dry weight and antihypertensive medications will be adjusted according to conventional office blood pressure measurements. Wearable blood pressure data will not be used for treatment decisions.
干预措施: Conventional office blood pressure-guided management (Device)
结局指标
主要结局
Achievement of target out-of-office blood pressure
时间窗: Week 10-11 (end of study)
Description: Out-of-office blood pressure control will be assessed at Week 10-11 using standardized Home Blood Pressure Monitoring (HBPM) in all randomized participants. Target blood pressure will be defined as a mean HBPM of \<135/85 mmHg. Individual target achievement will be classified as yes or no, and the group-level outcome will be expressed as the proportion of participants achieving the target, ranging from 0% to 100%. A higher proportion of participants achieving the target indicates better out-of-office blood pressure control. Time Frame: Week 10-11 (end of study)
次要结局
- Change in systolic and diastolic blood pressure((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Change in blood pressure variability((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Change in dry weight((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Change in antihypertensive medication use((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Incidence of treatment-related adverse events((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Device-related adverse events((1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11))
- Achievement of Target Blood Pressure Based on 24-hour Ambulatory Blood Pressure Monitoring (ABPM)(Week 10-11 (end of study))
研究者
Jong Hyun Jhee
Assistant Professor
Gangnam Severance Hospital