An interventional study of CART BP pro and Usual care (office BP-based management) in Hypertension, sponsored by Korea University Anam Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 288 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Participants undergo 24-hour continuous blood pressure monitoring with CART BP pro. Antihypertensive medications are adjusted based on ambulatory blood pressure data.
Device: CART BP pro
Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice.
Other: Usual care (office BP-based management)
Wearable cuffless continuous blood pressure monitoring device.
Standard hypertension management based on office blood pressure.
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.
Time frame: 24 weeks
Incidence of treatment-emergent adverse events (TEAE)
Proportion of participants experiencing TEAEs during the 24-week study period.
Time frame: 24 weeks
24-hour blood pressure load
Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours.
Time frame: 24 weeks
Office blood pressure change
Change in office systolic and diastolic blood pressure from baseline to 24 weeks.
Time frame: 24 weeks
Target blood pressure achievement rate
Proportion of participants achieving prespecified ambulatory BP targets.
Time frame: 24 weeks
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital