Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF

Summary

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.

Eligibility

Inclusion Criteria:

1. Age ≥ 19 years (male or female)
2. Diagnosed with heart failure and currently under treatment
3. Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment
4. Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement
5. Voluntarily provided written informed consent to participate in this clinical study

Exclusion Criteria:

1. Office blood pressure: SBP \< 90 mmHg, or DBP \< 50 mmHg, or SBP \> 180 mmHg, or DBP \> 100 mmHg
2. Unable to perform 24-hour ambulatory blood pressure monitoring
3. Unable to wear or use the ring-type blood pressure device
4. Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
5. 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
6. Pregnant, suspected pregnancy, or breastfeeding
7. Judged by the investigator to be legally or mentally unfit to participate in the clinical study

Conditions2

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