CART BP Pro-guided management for people with uncontrolled high blood pressure
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
Run by Korea University Anam Hospital · NCT07465549 · Data updated 2026-11-12
This project will see if using the wearable CART BP Pro ring to guide treatment helps lower blood pressure more than usual office-based care for adults in Korea whose blood pressure is not controlled.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Korea University Anam Hospital Academic / other |
| Drugs / interventions | CART |
| Locations | 3 sites (Ansan and 2 other locations) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07465549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older in Korea with office systolic blood pressure ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy and willing to provide consent and wear the device are ideal candidates.
✕Probably not a fit
Patients with atrial fibrillation, suspected secondary hypertension, pregnancy or lactation, intolerance to the study drug classes, or serious conditions that interfere with participation are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, open-label randomized trial in which adults with uncontrolled hypertension despite medication are randomized 1:1 to management guided by the CART BP Pro wearable cuffless ring or to usual care based on office blood pressure. The CART BP Pro uses photoplethysmography to estimate continuous ambulatory blood pressure and aims to provide more complete day-night and ambulatory blood pressure profiles than intermittent cuff measurements. Antihypertensive therapy in both arms follows guideline-based regimens using standard agents, and the primary endpoint is the difference in 24-hour mean systolic blood pressure at 24 weeks measured by ambulatory monitoring. Safety and feasibility of using the wearable device for treatment decisions are also monitored across participating Korean centers.
Why it matters
Potential benefit: If successful, the device-guided approach could improve blood pressure control by providing continuous, comfortable monitoring that helps clinicians tailor medications more precisely and potentially reduce cardiovascular risk.
How similar studies have gone: Small validation and feasibility studies of cuffless photoplethysmography devices have shown promising accuracy and usability, but large randomized trials demonstrating clinical outcome benefits are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Korea University Ansan Hospital
Ansan, South Korea Recruiting -
Korea University Anam Hospital
Seoul, South Korea Recruiting -
Korea University Guro Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hyung Joon Joo, MD PhD
- Email: drjoohj@korea.ac.kr
- Phone: +821034760526
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.