Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hou… (NCT07626879) | Clinical Trial Compass
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Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF
South Korea100 participantsStarted 2025-10-23
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
. 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