A prospective, single-arm, single-center, open-label, non-randomized clinical trial to evaluate the accuracy of the wrist-type 24-hour ambulatory blood pressure monitor (H2-ABPM) measuring blood pressure at the radial artery, compared with the arm-type aneroid 24-hour ambulatory blood pressure monitor.

A prospective, single-arm, single-center, open-label, non-randomized clinical trial to evaluate the accuracy of the wrist-type 24-hour ambulatory blood pressure monitor (H2-ABPM) measuring blood pressure at the radial artery, compared with the arm-type aneroid 24-hour ambulatory blood pressure monitor

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010553

Enrollment

100

Registered

2025-05-28

Start date

2025-04-29

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Each participant will simultaneously wear a wristband-type 24-hour ambulatory blood pressure monitor (H2-ABPM) and a reference 24-hour blood pressure monitoring device, with each devi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who meet the following criteria will be selected through simple random sampling. (1) Outpatients or inpatients aged 19 years or older who presented with hypotension, normotension, borderline hypertension, or hypertension. (2) Subjects who satisfied the target distribution criteria, including appropriate wrist circumference, age range, sex distribution, and upper arm circumference as defined in the study's sampling framework. (3) Subjects with a difference of 5 mmHg or less in systolic blood pressure between the left and right upper arms, as measured during screening. (4) Subjects who voluntarily agreed to participate in the study after receiving a detailed explanation, fully understanding the purpose and procedures of the clinical trial, and signing a written informed consent form agreeing to comply with study requirements.

Exclusion criteria

Exclusion criteria: (1) Patients who did not provide consent to participate in the study. (2) Patients with hypovolemia or similar conditions that could result in significant blood pressure fluctuations. (3) Patients taking vasopressors, antihypertensive medications, or similar drugs that may cause significant changes in blood pressure. (4) Pregnant, breastfeeding, or potentially pregnant individuals. (5) Other patients deemed unsuitable for the study based on the investigator's judgment.

Design outcomes

Primary

Measure	Time frame
ABPM-related outcome variables	—

Secondary

Measure	Time frame
Blood pressure measurement rate	—

Countries

Korea, Republic of

Contacts

Public ContactHong Euy Lim

Chung-Ang University Gwangmyeong Hospital

hongeuy1046@gmail.com+82-2-2222-1252

Outcome results