Feasibility and Effectiveness of a RING-type Blood Pressure Measurement Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device in Patients With Heart Failure With Reduced Ejection Fraction (RING-HFrEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
研究概览
简要总结
This study aims to evaluate the feasibility and diagnostic accuracy of the CART-BP ring-type wearable blood pressure monitoring device in comparison with 24-hour ambulatory blood pressure monitoring (ABPM) in patients with heart failure with reduced ejection fraction (HFrEF, LVEF ≤ 40%). As a multi-center, prospective, exploratory study, 100 patients will be enrolled at two tertiary hospitals in South Korea. The agreement between the two devices in 24-hour mean, daytime, and nighttime blood pressure measurements will be assessed per ISO 81060-2:2018 criteria.
详细描述
Hypertension is a major risk factor and exacerbating cause of heart failure. Accurate blood pressure monitoring in HFrEF patients is critically important, as reduced left ventricular stroke volume and altered peripheral vascular hemodynamics may affect the accuracy of photoplethysmography (PPG)-based blood pressure measurement.
The CART-BP device uses PPG technology in a ring form factor to enable continuous, non-invasive blood pressure monitoring. This study will simultaneously measure blood pressure using CART-BP and standard 24-hour ABPM over a 24-hour period. Agreement will be assessed using ISO 81060-2:2018 Criteria 1 and 2. An interim analysis will be conducted after 40 participants are enrolled to assess preliminary agreement and determine whether to continue to the full enrollment of 100 participants.
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
- •Age ≥ 19 years (male or female)
- •Diagnosed with heart failure and currently under treatment
- •Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment
- •Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement
- •Voluntarily provided written informed consent to participate in this clinical study
排除标准
- •Office blood pressure: SBP < 90 mmHg, or DBP < 50 mmHg, or SBP > 180 mmHg, or DBP > 100 mmHg
- •Unable to perform 24-hour ambulatory blood pressure monitoring
- •Unable to wear or use the ring-type blood pressure device
- •Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
- •Insufficient valid ABPM readings: < 25 daytime or < 12 nighttime measurements per ESH criteria; or < 25 daytime or < 12 nighttime valid readings from the ring-type device
- •Pregnant, suspected pregnancy, or breastfeeding
- •Judged by the investigator to be legally or mentally unfit to participate in the clinical study
研究组 & 干预措施
Heart failure with reduced ejection fraction
Heart failure with reduced ejection fraction with or without hypertension
结局指标
主要结局
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
时间窗: 24 hours
Agreement between the CART-BP ring-type device and the 24-hour ABPM for mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), evaluated according to ISO 81060-2:2018 Criteria 1 and 2 (Opposite arm simultaneous method, section 5.2.4.2.2)
次要结局
- Blood pressure variability (standard deviation) agreement between devices(24 hours)
- Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients)(24 hours)
- Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients)(24 hours)
- Agreement in nighttime mean SBP and DBP between CART-BP and ABPM(24 hours)
- Agreement in blood pressure dipping pattern between CART-BP and ABPM(24 hours)
- Agreement in daytime mean SBP and DBP between CART-BP and ABPM(24 hours)
研究者
In-Cheol Kim
Associate Professor
Keimyung University Dongsan Medical Center