CART-BP Prospective Study for Hypertension Control

NCT07454148 | Active Not Recruiting

• 1 other identifier: CARTBP-HTN-P1-2025
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.

  24 weeks

Secondary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAE)

  24 weeks

• 24-hour blood pressure load

  24 weeks

• Office blood pressure change

  24 weeks

• Target blood pressure achievement rate

  24 weeks

Study Arms (2)

CART BP pro-guided management

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice.

Other: Usual care (office BP-based management)

Interventions

CART BP pro DEVICE

Wearable cuffless continuous blood pressure monitoring device.

CART BP pro-guided management

Usual care (office BP-based management) OTHER

Standard hypertension management based on office blood pressure.

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

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

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

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

Model Details: Participants are allocated to either a CART BP Pro-guided management group or a usual care group. Treatment decisions in the CART BP Pro-guided group are informed by continuous ambulatory blood pressure data obtained from the wearable device, whereas treatment decisions in the usual care group are based on conventional office blood pressure measurements.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 25, 2025
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)