An observational study in Heart Failure With Reduced Ejection Fraction; Hypertension, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Keimyung University Dongsan Medical Center · Observational
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.
Hypertension is a major risk factor and exacerbating cause of heart failure. Accurate blood pressure monitoring in HFrEF patients is critically important, as reduced left ventricular stroke volume and altered peripheral vascular hemodynamics may affect the accuracy of photoplethysmography (PPG)-based blood pressure measurement.
The CART-BP device uses PPG technology in a ring form factor to enable continuous, non-invasive blood pressure monitoring. This study will simultaneously measure blood pressure using CART-BP and standard 24-hour ABPM over a 24-hour period. Agreement will be assessed using ISO 81060-2:2018 Criteria 1 and 2. An interim analysis will be conducted after 40 participants are enrolled to assess preliminary agreement and determine whether to continue to the full enrollment of 100 participants.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 100 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.
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Heart Failure with Reduced Ejection Fraction patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Heart failure with reduced ejection fraction with or without hypertension
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
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)
Time frame: 24 hours
Agreement in daytime mean SBP and DBP between CART-BP and ABPM
Time frame: 24 hours
Agreement in nighttime mean SBP and DBP between CART-BP and ABPM
Time frame: 24 hours
Agreement in blood pressure dipping pattern between CART-BP and ABPM
Time frame: 24 hours
Blood pressure variability (standard deviation) agreement between devices
Time frame: 24 hours
Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients)
Time frame: 24 hours
Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients)
Time frame: 24 hours
Plan to share: Undecided
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Keimyung University Dongsan Medical Center