CART-BP Prospective Study for Hypertension Control

Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management in Korean Patients With Uncontrolled Hypertension: A Prospective Non-Randomized Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: CART BP pro; Other: Usual care (office BP-based management)

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Choose One...
    • Seoul, Choose One..., South Korea, 02841
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CART BP pro-guided management; 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; Wearable cuffless continuous blood pressure monitoring device.
Active Comparator: Usual care; Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice.	Other: Usual care (office BP-based management); Standard hypertension management based on office blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): May 4, 2026
• Study Completion (Estimated): May 4, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Ambulatory blood pressure monitoring; Cuffless blood pressure monitoring; Wearable blood pressure device; CART BP Pro
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: CARTBP-HTN-P1-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No