Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF
Recruiting now
Conditions studied: Heart Failure With Reduced Ejection Fraction; Hypertension
In brief
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.
Key facts
- Study ID
- NCT07626879
- Run by
- Keimyung University Dongsan Medical Center
- People needed
- 100
- Starts
- 2025-10-23
- Expected to finish
- 2026-10-22
- Last updated by the study team
- 2026-06-04
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 19 years (male or female)
- Diagnosed with heart failure and currently under treatment
- Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment
- Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement
- Voluntarily provided written informed consent to participate in this clinical study
You may not qualify if…
- Office blood pressure: SBP < 90 mmHg, or DBP < 50 mmHg, or SBP > 180 mmHg, or DBP > 100 mmHg
- Unable to perform 24-hour ambulatory blood pressure monitoring
- Unable to wear or use the ring-type blood pressure device
- Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
- 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
- Pregnant, suspected pregnancy, or breastfeeding
- Judged by the investigator to be legally or mentally unfit to participate in the clinical study
Where it is running
- Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
Full record on ClinicalTrials.gov
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