Evaluation of Cuffless Blood Pressure Monitoring in Hemodialysis (CURE-HD) Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Reproducibility and agreement of CART BP Pro measurements
研究概览
简要总结
This is a prospective, multicenter observational cohort study designed to evaluate the validity and clinical utility of cuffless blood pressure monitoring using the CART BP Pro device in patients receiving maintenance hemodialysis. Blood pressure measured using the CART BP Pro device will be compared with 24-hour ambulatory blood pressure monitoring (ABPM) and conventional pre-dialysis blood pressure measurements to evaluate its validity. The reproducibility of cuffless blood pressure measurements will also be assessed through repeated measurements performed at one-week intervals. In addition, the associations between blood pressure parameters measured using the CART BP Pro device and cardiovascular indicators, including echocardiographic parameters, coronary artery calcium score, body composition measurements, and clinical outcomes, will be prospectively evaluated during a 12-month follow-up period.
The study hypothesizes that cuffless blood pressure monitoring using the CART BP Pro device provides valid and reproducible blood pressure measurements in patients receiving maintenance hemodialysis. Furthermore, blood pressure parameters measured using the CART BP Pro device are expected to demonstrate stronger associations with cardiovascular indicators and to provide better prediction of cardiovascular events and all-cause mortality than conventional pre-dialysis blood pressure measurements and 24-hour ambulatory blood pressure monitoring.
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
- 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
- •Receiving maintenance hemodialysis three times per week
- •Receiving maintenance hemodialysis for at least 3 months
- •Able and willing to provide written informed consent
排除标准
- •Presence of a cardiac pacemaker or clinically significant arrhythmia (e.g., atrial fibrillation). Patients with paroxysmal atrial fibrillation are eligible for enrollment.
- •Unable to wear the CART BP Pro device (e.g., finger deformity)
- •Expected survival of less than 6 months
研究组 & 干预措施
Maintenance Hemodialysis Patients
Adult patients (≥19 years) receiving maintenance hemodialysis for at least 3 months who meet the eligibility criteria. Participants will undergo cuffless blood pressure monitoring using the CART BP Pro device, conventional pre-dialysis blood pressure measurement, and 24-hour ambulatory blood pressure monitoring according to the study protocol. Blood pressure variability, measurement reproducibility, cardiovascular parameters, and clinical outcomes will be prospectively evaluated over a 12-month follow-up.
干预措施: CART BP Pro (Device)
结局指标
主要结局
Reproducibility and agreement of CART BP Pro measurements
时间窗: At baseline (first study dialysis session) and at 6 and 12 months after the baseline assessment
Continuous blood pressure measurements (systolic, diastolic, and mean arterial pressure) expressed in mmHg. Agreement between CART BP Pro and ABPM(Ambulatory Blood Pressure Monitoring) will be assessed using Bland-Altman analysis, intraclass correlation coefficients (ICC), and mixed-effects models. Reproducibility of CART BP Pro measurements will be evaluated using repeated-measures analyses across the study visits. Higher agreement (smaller mean bias and narrower limits of agreement) and higher ICC values indicate better measurement performance.
次要结局
未报告次要终点
研究者
Jong Hyun Jhee
Assistant Professor
Gangnam Severance Hospital