An interventional study of CART BP Pro and Usual Care in Hypertension, sponsored by Korea University Anam Hospital. Recruiting at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Treatment
This multicenter, prospective, open-label randomized controlled trial evaluates the efficacy and safety of CART BP Pro-guided blood pressure management in Korean patients with uncontrolled hypertension. CART BP Pro is a wearable cuffless blood pressure monitoring device based on photoplethysmography technology that enables continuous ambulatory blood pressure monitoring.
Eligible participants with uncontrolled hypertension despite ongoing antihypertensive therapy will be randomly assigned in a 1:1 ratio to either a CART BP Pro-guided management group or a usual care group based on conventional office blood pressure measurements. Antihypertensive treatment in both groups will follow guideline-based therapy using standard agents including angiotensin receptor blockers, calcium channel blockers, and thiazide diuretics.
The primary efficacy endpoint is the between-group difference in 24-hour mean systolic blood pressure at 24 weeks measured using ambulatory blood pressure monitoring. Safety will be assessed by the incidence of treatment-emergent adverse events during the study period.
Hypertension remains one of the most prevalent chronic conditions worldwide and is a major contributor to cardiovascular morbidity and mortality. Although multiple antihypertensive medications are widely used, a substantial proportion of patients remain inadequately controlled. Office blood pressure measurements alone may not adequately reflect the true blood pressure burden or nocturnal blood pressure patterns. Ambulatory blood pressure monitoring provides a more comprehensive assessment of blood pressure variability and control but is limited by patient discomfort and practical constraints. Recently developed wearable cuffless blood pressure monitoring devices have the potential to provide continuous and convenient blood pressure assessment in real-world settings.
CART BP Pro is a wearable ring-type device that uses photoplethysmography-based technology to estimate continuous ambulatory blood pressure. Compared with conventional cuff-based ambulatory blood pressure monitoring, the device allows more comfortable long-term monitoring and may facilitate improved hypertension management.
This study is designed as a multicenter, prospective, open-label randomized controlled trial conducted at Korea University Anam Hospital, Korea University Guro Hospital, and Korea University Ansan Hospital. Adult patients with uncontrolled hypertension despite ongoing antihypertensive therapy will be enrolled and randomized to either CART BP Pro-guided management or usual care. In the intervention group, antihypertensive treatment adjustments will be guided by blood pressure information obtained from the CART BP Pro device. In the control group, treatment decisions will be based on conventional office blood pressure measurements according to standard clinical practice. Participants will be followed for 24 weeks to evaluate blood pressure control and safety outcomes. An optional extended follow-up to 48 weeks may be performed for additional observational analysis.
The study aims to determine whether CART BP Pro-guided blood pressure management improves ambulatory blood pressure control compared with usual care in real-world clinical practice.
Exclusion Criteria:
Participants will undergo ambulatory blood pressure monitoring using the CART BP Pro wearable device. Antihypertensive medication adjustments will be guided by ambulatory blood pressure data obtained from the device.
Device: CART BP Pro
Participants will receive standard hypertension management based on office blood pressure measurements according to current clinical guidelines.
Other: Usual Care
CART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.
Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.
24-hour mean systolic blood pressure
Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.
Time frame: 24 weeks
Incidence of treatment-emergent adverse events (TEAEs)
Proportion of participants experiencing treatment-emergent adverse events during the study period.
Time frame: 24 weeks
24-hour blood pressure load
Percentage of ambulatory blood pressure measurements exceeding predefined systolic or diastolic blood pressure thresholds over a 24-hour monitoring period.
Time frame: 24 weeks
Target blood pressure achievement rate
Proportion of participants achieving predefined ambulatory blood pressure targets.
Time frame: 24 weeks
Mean daytime and nighttime blood pressure
Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring.
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
Plan to share: No — De-identified individual participant data collected in this study will not be shared with external researchers at this time. Data sharing may be considered in the future subject to institutional review board approval and institutional data governance policies.
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Korea University Anam Hospital