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Recruiting Not applicable

CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

NCT07465549 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-10-22
Last updated
2026-04-30

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

CART BP ProUsual Care

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.

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

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 19 years 2. Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg 3. Ability and willingness to provide written informed consent and comply with study procedures Exclusion Criteria: 1. History of intolerance or contraindication to olmesartan, amlodipine, or hydrochlorothiazide 2. Suspected secondary hypertension 3. Atrial fibrillation 4. Pregnancy or lactation 5. Any serious medical condition that may interfere with study participation or interpretation of study results

Primary outcome measure(s)

  • 24-hour mean systolic blood pressure — 24 weeks
    Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.

Trial sites (3)

FacilityCityRegionStatus
Korea University Ansan Hospital Ansan South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465549 on ClinicalTrials.gov ↗ ← All trials in South Korea