RecruitingNot ApplicableNCT07465549

CART BP Pro-Guided Blood Pressure Management in Patients With Uncontrolled Hypertension: A Multicenter Randomized Controlled Trial

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


Sponsor

Korea University Anam Hospital

Enrollment

400 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria4

  • Age ≥ 19 years
  • Diagnosis of hypertension with ongoing antihypertensive treatment for at least one year
  • Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
  • Ability and willingness to provide written informed consent and comply with study procedures

Exclusion Criteria5

  • History of intolerance or contraindication to olmesartan, amlodipine, or hydrochlorothiazide
  • Suspected secondary hypertension
  • Atrial fibrillation
  • Pregnancy or lactation
  • Any serious medical condition that may interfere with study participation or interpretation of study results

Interventions

DEVICECART 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.

OTHERUsual 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

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NCT07465549


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