An observational study in End-Stage Renal Disease, sponsored by Gangnam Severance Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Gangnam Severance Hospital · Observational
This is a prospective, multicenter observational cohort study designed to evaluate the validity and clinical utility of cuffless blood pressure monitoring using the CART BP Pro device in patients receiving maintenance hemodialysis. Blood pressure measured using the CART BP Pro device will be compared with 24-hour ambulatory blood pressure monitoring (ABPM) and conventional pre-dialysis blood pressure measurements to evaluate its validity. The reproducibility of cuffless blood pressure measurements will also be assessed through repeated measurements performed at one-week intervals. In addition, the associations between blood pressure parameters measured using the CART BP Pro device and cardiovascular indicators, including echocardiographic parameters, coronary artery calcium score, body composition measurements, and clinical outcomes, will be prospectively evaluated during a 12-month follow-up period.
The study hypothesizes that cuffless blood pressure monitoring using the CART BP Pro device provides valid and reproducible blood pressure measurements in patients receiving maintenance hemodialysis. Furthermore, blood pressure parameters measured using the CART BP Pro device are expected to demonstrate stronger associations with cardiovascular indicators and to provide better prediction of cardiovascular events and all-cause mortality than conventional pre-dialysis blood pressure measurements and 24-hour ambulatory blood pressure monitoring.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 240 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Gangnam Severance Hospital is the lead sponsor of 146 studies on the registry; 38 are open to participants now.
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Adult patients receiving maintenance hemodialysis for at least 3 months at Gangnam Severance Hospital, Yongin Severance Hospital, and Catholic Kwandong University International St. Mary's Hospital in South Korea will be screened for eligibility. Patients who meet the inclusion and exclusion criteria and provide written informed consent will be prospectively enrolled in the study.
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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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (≥19 years) receiving maintenance hemodialysis for at least 3 months who meet the eligibility criteria. Participants will undergo cuffless blood pressure monitoring using the CART BP Pro device, conventional pre-dialysis blood pressure measurement, and 24-hour ambulatory blood pressure monitoring according to the study protocol. Blood pressure variability, measurement reproducibility, cardiovascular parameters, and clinical outcomes will be prospectively evaluated over a 12-month follow-up.
Device: CART BP Pro
Participants will wear the CART BP Pro, a cuffless ring-type blood pressure monitoring device, on the index finger of the non-vascular access hand. The device will automatically measure blood pressure at 20-minute intervals over approximately 48 hours during each scheduled assessment period. Blood pressure data obtained from the device will be compared with conventional pre-dialysis blood pressure measurements and 24-hour ambulatory blood pressure monitoring.
Also known as: Cuffless Blood Pressure Monitoring Device
Reproducibility and agreement of CART BP Pro measurements
Continuous blood pressure measurements (systolic, diastolic, and mean arterial pressure) expressed in mmHg. Agreement between CART BP Pro and ABPM(Ambulatory Blood Pressure Monitoring) will be assessed using Bland-Altman analysis, intraclass correlation coefficients (ICC), and mixed-effects models. Reproducibility of CART BP Pro measurements will be evaluated using repeated-measures analyses across the study visits. Higher agreement (smaller mean bias and narrower limits of agreement) and higher ICC values indicate better measurement performance.
Time frame: At baseline (first study dialysis session) and at 6 and 12 months after the baseline assessment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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