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RECRUITING
NCT07465549
NA

CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

Sponsor: Korea University Anam Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-10-22

Completion Date

2027-07-31

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

CART BP Pro

CART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.

OTHER

Usual Care

Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.

Locations (3)

Korea University Ansan Hospital

Ansan, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea