Hypertension
Conditions
Keywords
Hypertension, Ambulatory blood pressure monitoring, Cuffless blood pressure monitoring, Wearable blood pressure device, CART BP Pro
Brief summary
This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Participants are allocated to either a CART BP pro-guided management group or a usual care group based on clinical decision and participant preference. The primary efficacy endpoint is 24-hour mean ambulatory systolic blood pressure at 24 weeks; safety outcomes including treatment-emergent adverse events (TEAEs) are also assessed.
Detailed description
Hypertension remains suboptimally controlled despite combination pharmacotherapy, and office blood pressure measurements may not adequately reflect true ambulatory blood pressure burden and nocturnal patterns. CART BP pro is a wearable, cuffless photoplethysmography-based continuous blood pressure monitoring device. This study investigates whether a CART BP pro-guided antihypertensive titration strategy improves 24-hour ambulatory blood pressure control compared with usual care in real-world outpatient settings. Participants receive standard antihypertensive medications (e.g., angiotensin receptor blocker \[ARB\], calcium channel blocker \[CCB\], thiazide diuretic) per guideline-based care. In the CART BP pro-guided group, medication adjustments are informed by CART BP pro-derived 24-hour blood pressure data. Follow-up is 24 weeks with optional extended follow-up to 48 weeks.
Interventions
DEVICECART BP pro
Wearable cuffless continuous blood pressure monitoring device.
OTHERUsual care (office BP-based management)
Standard hypertension management based on office blood pressure.
Sponsors
Korea University Anam Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are allocated to either a CART BP Pro-guided management group or a usual care group. Treatment decisions in the CART BP Pro-guided group are informed by continuous ambulatory blood pressure data obtained from the wearable device, whereas treatment decisions in the usual care group are based on conventional office blood pressure measurements.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 19 years 2. Office systolic blood pressure(BP) \>= 140 mmHg or diastolic BP \>= 90 mmHg 3. Able and willing to provide written informed consent and comply with follow-up visits
Exclusion criteria
1. History of intolerance to olmesartan, amlodipine, or hydrochlorothiazide 2. Suspected secondary hypertension 3. Atrial fibrillation 4. Pregnancy or lactation 5. Other serious medical condition that may interfere with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour mean systolic blood pressure | 24 weeks | Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target blood pressure achievement rate | 24 weeks | Proportion of participants achieving prespecified ambulatory BP targets. |
| Incidence of treatment-emergent adverse events (TEAE) | 24 weeks | Proportion of participants experiencing TEAEs during the 24-week study period. |
| 24-hour blood pressure load | 24 weeks | Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours. |
| Office blood pressure change | 24 weeks | Change in office systolic and diastolic blood pressure from baseline to 24 weeks. |
Countries
South Korea
Outcome results
None listed