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NCT Number: NCT07454148

CART-BP Prospective Study for Hypertension Control

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, Choose One..., 02841, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 19 years
  • Office systolic blood pressure(BP) >= 140 mmHg or diastolic BP >= 90 mmHg
  • Able and willing to provide written informed consent and comply with follow-up visits

Exclusion criteria

  • History of intolerance to olmesartan, amlodipine, or hydrochlorothiazide
  • Suspected secondary hypertension
  • Atrial fibrillation
  • Pregnancy or lactation
  • Other serious medical condition that may interfere with study participation

Treatment and study plan

CART BP pro

Device

Wearable cuffless continuous blood pressure monitoring device.

Usual care (office BP-based management)

Other

Standard hypertension management based on office blood pressure.

Primary outcomes

  1. 24-hour mean systolic blood pressure

    Time frame: 24 weeks

    Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (TEAE)

    Time frame: 24 weeks

    Proportion of participants experiencing TEAEs during the 24-week study period.

  2. 24-hour blood pressure load

    Time frame: 24 weeks

    Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours.

  3. Office blood pressure change

    Time frame: 24 weeks

    Change in office systolic and diastolic blood pressure from baseline to 24 weeks.

  4. Target blood pressure achievement rate

    Time frame: 24 weeks

    Proportion of participants achieving prespecified ambulatory BP targets.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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