Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CART BP pro-guided management | Experimental | Participants undergo 24-hour continuous blood pressure monitoring with CART BP pro. Antihypertensive medications are adjusted based on ambulatory blood pressure data. |
|
| Usual care | Active Comparator | Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART BP pro | Device | Wearable cuffless continuous blood pressure monitoring device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour mean systolic blood pressure | Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAE) | Proportion of participants experiencing TEAEs during the 24-week study period. | 24 weeks |
| 24-hour blood pressure load | Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | Choose One... | 02841 | South Korea |
De-identified individual participant data collected in this study are not currently planned to be shared with external researchers. Data sharing may be considered in the future subject to institutional review board approval and institutional data governance policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Usual care (office BP-based management) | Other | Standard hypertension management based on office blood pressure. |
|
| 24 weeks |
| Office blood pressure change | Change in office systolic and diastolic blood pressure from baseline to 24 weeks. | 24 weeks |
| Target blood pressure achievement rate | Proportion of participants achieving prespecified ambulatory BP targets. | 24 weeks |