Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF
Recruiting · NCT07626879 · Observational (researchers observe without assigning treatment) · Lead sponsor: Keimyung University Dongsan Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed.
- Keimyung University Dongsan Medical Center - Daegu, South Korea
- Keimyung University Dongsan Medical Center - Daegu, South Korea