CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension (CART-BP RCT)

April 26, 2026 updated by: Hyung Joon Joo, Korea University Anam Hospital

Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management Compared With Usual Care in Korean Patients With Uncontrolled Hypertension: A Multicenter Prospective Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Ansan, South Korea
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
        • Principal Investigator:
          • Seung Yong Shin, MD PhD
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Hyung Joon Joo, MD PhD
        • Sub-Investigator:
          • Cheol Woong Yu, MD PhD
        • Sub-Investigator:
          • Dong-Hyuk Cho, MD PhD
        • Sub-Investigator:
          • Jung-Joon Cha, MD PhD
        • Sub-Investigator:
          • Mi-Na Kim, MD PhD
        • Sub-Investigator:
          • Jae Hyoung Park, MD PhD
        • Sub-Investigator:
          • Se Won Oh, MD PhD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Soohyung Park, MD PhD
        • Sub-Investigator:
          • Ji Eun Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CART BP Pro-guided blood pressure management
Participants will undergo ambulatory blood pressure monitoring using the CART BP Pro wearable device. Antihypertensive medication adjustments will be guided by ambulatory blood pressure data obtained from the device.
Device: CART 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.
Active Comparator: Usual care
Participants will receive standard hypertension management based on office blood pressure measurements according to current clinical guidelines.
Other: Usual Care
Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour mean systolic blood pressure
Time Frame: 24 weeks
Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Office blood pressure change
Time Frame: 24 weeks
Change in office systolic and diastolic blood pressure from baseline to 24 weeks.
24 weeks
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 24 weeks
Proportion of participants experiencing treatment-emergent adverse events during the study period.
24 weeks
24-hour blood pressure load
Time Frame: 24 weeks
Percentage of ambulatory blood pressure measurements exceeding predefined systolic or diastolic blood pressure thresholds over a 24-hour monitoring period.
24 weeks
Target blood pressure achievement rate
Time Frame: 24 weeks
Proportion of participants achieving predefined ambulatory blood pressure targets.
24 weeks
Mean daytime and nighttime blood pressure
Time Frame: 24 weeks
Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CARTBP-HTN-P2-2025

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 will not be shared with external researchers at this time. 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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