CART BP Pro-guided management for people with uncontrolled high blood pressure
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Drugs / interventions | CART |
| Locations | 3 sites (Ansan and 2 other locations) |
| Trial ID | NCT07465549 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ansan and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.