CART BP pro
DeviceCART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.
NCT Number: NCT07465549
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Korea University Ansan Hospital, Ansan, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 weeks
Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.
Time frame: 24 weeks
Proportion of participants experiencing treatment-emergent adverse events during the study period.
Time frame: 24 weeks
Percentage of ambulatory blood pressure measurements exceeding predefined systolic or diastolic blood pressure thresholds over a 24-hour monitoring period.
Time frame: 24 weeks
Proportion of participants achieving predefined ambulatory blood pressure targets.
Time frame: 24 weeks
Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring.
Time frame: 24 weeks
Change in office systolic and diastolic blood pressure from baseline to 24 weeks.
Contact information is provided by the study sponsor or research team.
Korea University Anam Hospital
Other
Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management Compared With Usual Care in Korean Patients With Uncontrolled Hypertension: A Multicenter Prospective Randomized Controlled Trial
Acronym: CART-BP RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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