Cuffless BP Monitoring in Hemodialysis

N/AEnrolling By InvitationNCT07753876

Gangnam Severance Hospital240 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

End-Stage Renal Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 19 years or older * Receiving maintenance hemodialysis three times per week * Receiving maintenance hemodialysis for at least 3 months * Able and willing to provide written informed consent Exclusion Criteria: * Presence of a cardiac pacemaker or clinically significant arrhythmia (e.g., atrial fibrillation). Patients with paroxysmal atrial fibrillation are eligible for enrollment. * Unable to wear the CART BP Pro device (e.g., finger deformity) * Expected survival of less than 6 months

Outcomes

Primary Outcomes

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