Hypertension
Conditions
Keywords
Hypertension, Ambulatory blood pressure monitoring, Cuffless blood pressure monitoring, Wearable blood pressure device, CART BP Pro
Brief 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.
Detailed description
Hypertension remains one of the most prevalent chronic conditions worldwide and is a major contributor to cardiovascular morbidity and mortality. Although multiple antihypertensive medications are widely used, a substantial proportion of patients remain inadequately controlled. Office blood pressure measurements alone may not adequately reflect the true blood pressure burden or nocturnal blood pressure patterns. Ambulatory blood pressure monitoring provides a more comprehensive assessment of blood pressure variability and control but is limited by patient discomfort and practical constraints. Recently developed wearable cuffless blood pressure monitoring devices have the potential to provide continuous and convenient blood pressure assessment in real-world settings. CART BP Pro is a wearable ring-type device that uses photoplethysmography-based technology to estimate continuous ambulatory blood pressure. Compared with conventional cuff-based ambulatory blood pressure monitoring, the device allows more comfortable long-term monitoring and may facilitate improved hypertension management. This study is designed as a multicenter, prospective, open-label randomized controlled trial conducted at Korea University Anam Hospital, Korea University Guro Hospital, and Korea University Ansan Hospital. Adult patients with uncontrolled hypertension despite ongoing antihypertensive therapy will be enrolled and randomized to either CART BP Pro-guided management or usual care. In the intervention group, antihypertensive treatment adjustments will be guided by blood pressure information obtained from the CART BP Pro device. In the control group, treatment decisions will be based on conventional office blood pressure measurements according to standard clinical practice. Participants will be followed for 24 weeks to evaluate blood pressure control and safety outcomes. An optional extended follow-up to 48 weeks may be performed for additional observational analysis. The study aims to determine whether CART BP Pro-guided blood pressure management improves ambulatory blood pressure control compared with usual care in real-world clinical practice.
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.
Sponsors
Korea University Anam Hospital
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the CART BP Pro-guided management group or the usual care group using an electronic case report form-based randomization system. Antihypertensive treatment will be adjusted according to ambulatory blood pressure data obtained from the CART BP Pro device in the intervention group and according to conventional office blood pressure measurements in the usual care group.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour mean systolic blood pressure | 24 weeks | Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | 24 weeks | Proportion of participants experiencing treatment-emergent adverse events during the study period. |
| 24-hour blood pressure load | 24 weeks | Percentage of ambulatory blood pressure measurements exceeding predefined systolic or diastolic blood pressure thresholds over a 24-hour monitoring period. |
| Target blood pressure achievement rate | 24 weeks | Proportion of participants achieving predefined ambulatory blood pressure targets. |
| Mean daytime and nighttime blood pressure | 24 weeks | Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring. |
| Office blood pressure change | 24 weeks | Change in office systolic and diastolic blood pressure from baseline to 24 weeks. |
Countries
South Korea
Contacts
CONTACTHyung Joon Joo, MD PhD
Outcome results
None listed