RecruitingNot ApplicableNCT07465549

CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood pressure management app called CART BP Pro, combined with a specific combination blood pressure medication, can help people with uncontrolled high blood pressure better manage their condition. The app guides medication adjustments based on home blood pressure readings. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with hypertension and have been on blood pressure medication for at least one year - Your blood pressure is still not well controlled (systolic ≥140 mmHg or diastolic ≥90 mmHg) - You are willing and able to participate and provide consent **You may NOT be eligible if...** - You have an allergy or contraindication to olmesartan, amlodipine, or hydrochlorothiazide - Your high blood pressure is caused by another medical condition (secondary hypertension) - You have atrial fibrillation (an irregular heart rhythm) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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