This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Participants are allocated to either a CART BP pro-guided management group or a usual care group based on clinical decision and participant preference. The primary efficacy endpoint is 24-hour mean ambulatory systolic blood pressure at 24 weeks; safety outcomes including treatment-emergent adverse events (TEAEs) are also assessed.
Hypertension remains suboptimally controlled despite combination pharmacotherapy, and office blood pressure measurements may not adequately reflect true ambulatory blood pressure burden and nocturnal patterns. CART BP pro is a wearable, cuffless photoplethysmography-based continuous blood pressure monitoring device. This study investigates whether a CART BP pro-guided antihypertensive titration strategy improves 24-hour ambulatory blood pressure control compared with usual care in real-world outpatient settings. Participants receive standard antihypertensive medications (e.g., angiotensin receptor blocker \[ARB\], calcium channel blocker \[CCB\], thiazide diuretic) per guideline-based care. In the CART BP pro-guided group, medication adjustments are informed by CART BP pro-derived 24-hour blood pressure data. Follow-up is 24 weeks with optional extended follow-up to 48 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Wearable cuffless continuous blood pressure monitoring device.
Standard hypertension management based on office blood pressure.
Korea University Anam Hospital
Seoul, Choose One..., South Korea
24-hour mean systolic blood pressure
Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.
Time frame: 24 weeks
Incidence of treatment-emergent adverse events (TEAE)
Proportion of participants experiencing TEAEs during the 24-week study period.
Time frame: 24 weeks
24-hour blood pressure load
Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours.
Time frame: 24 weeks
Office blood pressure change
Change in office systolic and diastolic blood pressure from baseline to 24 weeks.
Time frame: 24 weeks
Target blood pressure achievement rate
Proportion of participants achieving prespecified ambulatory BP targets.
Time frame: 24 weeks
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