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.
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
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)
Heart Failure with Reduced Ejection Fraction patients
Cohort
Prospective
Not listed
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
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)
Agreement in daytime mean SBP and DBP between CART-BP and ABPM
Agreement in nighttime mean SBP and DBP between CART-BP and ABPM
Agreement in blood pressure dipping pattern between CART-BP and ABPM
Blood pressure variability (standard deviation) agreement between devices
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