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Cuffless BP Monitoring in Hemodialysis

NCT07753876 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • ESRD on HD

Interventions

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.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-08-01
Completion
2026-09-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753876 on ClinicalTrials.gov