NCT07626879Recruiting
Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF
Feasibility and Effectiveness of a RING-type Blood Pressure Measurement Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device in Patients With Heart Failure With Reduced Ejection Fraction (RING-HFrEF)
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 29 May 2026
- Start date
- 23 Oct 2025
- Primary completion date
- 22 Oct 2026
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT07626879
What you commit to
- Study type: Observational
- Planned participants: 100
- From 23 Oct 2025 to the primary completion date, 22 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.