CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

NCT07465549 | Recruiting DMC

• 1 other identifier: CARTBP-HTN-P2-2025
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Keywords

Hypertension; Ambulatory blood pressure monitoring; Cuffless blood pressure monitoring; Wearable blood pressure device; CART BP Pro

Outcome Measures

Primary Outcomes (1)

• 24-hour mean systolic blood pressure

  Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.

  24 weeks

Secondary Outcomes (5)

• Incidence of treatment-emergent adverse events (TEAEs)

  24 weeks

• 24-hour blood pressure load

  24 weeks

• Target blood pressure achievement rate

  24 weeks

• Mean daytime and nighttime blood pressure

  24 weeks

• Office blood pressure change

  24 weeks

Study Arms (2)

CART BP Pro-guided blood pressure management

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Participants will receive standard hypertension management based on office blood pressure measurements according to current clinical guidelines.

Other: Usual Care

Interventions

CART BP Pro DEVICE

CART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.

CART BP Pro-guided blood pressure management

Usual Care OTHER

Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.

Usual care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
• Ability and willingness to provide written informed consent and comply with study procedures

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (3)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hyung Joon Joo, MD PhD

CONTACT

+821034760526; drjoohj@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)