Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device

Seoul National University Hospital40 enrolled

Overview

The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hypertension Blood Pressure Systolic Hypertension Diastolic Hypertension Essential Hypertension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension 2. Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes * Either criterion 1 or 2 are planned to be selected as study participants. Exclusion Criteria: * Participants who do not consent to the study * Individuals with a Body Mass Index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well) * Pregnancy * Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction * Patients diagnosed with atrial fibrillation on a 12 lead EKG within the past 6 months * End-stage renal disease (patients undergoing dialysis) * Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study

Outcomes

Primary Outcomes

The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time.

Time frame: Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.

Central Contacts

Hae-Young Lee, Professor

CONTACT

+82-02-2072-0698 hylee612@snu.ac.kr

Huijin Lee, Clinical Fellow