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Clinical Trials in South Korea / NCT07626879
Recruiting Observational

Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF

NCT07626879 · tracked via the Priya Life Science South Korea tracker
Sponsor
Keimyung University Dongsan Medical Center
Phase
Observational
Started
2025-10-23
Last updated
2026-06-04

Condition(s) studied

Heart Failure With Reduced Ejection Fraction; Hypertension

Study summary

This study aims to evaluate the feasibility and diagnostic accuracy of the CART-BP ring-type wearable blood pressure monitoring device in comparison with 24-hour ambulatory blood pressure monitoring (ABPM) in patients with heart failure with reduced ejection fraction (HFrEF, LVEF ≤ 40%). As a multi-center, prospective, exploratory study, 100 patients will be enrolled at two tertiary hospitals in South Korea. The agreement between the two devices in 24-hour mean, daytime, and nighttime blood pressure measurements will be assessed per ISO 81060-2:2018 criteria.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 19 years (male or female) 2. Diagnosed with heart failure and currently under treatment 3. Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment 4. Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement 5. Voluntarily provided written informed consent to participate in this clinical study Exclusion Criteria: 1. Office blood pressure: SBP \< 90 mmHg, or DBP \< 50 mmHg, or SBP \> 180 mmHg, or DBP \> 100 mmHg 2. Unable to perform 24-hour ambulatory blood pressure monitoring 3. Unable to wear or use the ring-type blood pressure device 4. Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP) 5. Insufficient valid ABPM readings: \< 25 daytime or \< 12 nighttime measurements per ESH criteria; or \< 25 daytime or \< 12 nighttime valid readings from the ring-type device 6. Pregnant, suspected pregnancy, or breastfeeding 7. Judged by the investigator to be legally or mentally unfit to participate in the clinical study

Primary outcome measure(s)

  • Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure — 24 hours
    Agreement between the CART-BP ring-type device and the 24-hour ABPM for mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), evaluated according to ISO 81060-2:2018 Criteria 1 and 2 (Opposite arm simultaneous method, section 5.2.4.2.2)

Trial sites (1)

FacilityCityRegionStatus
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626879 on ClinicalTrials.gov ↗ ← All trials in South Korea