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Cuffless BP Monitoring in Hemodialysis

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv2
  2. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07753876
Lead Sponsor Gangnam Severance Hospital
Conditions
(from sponsor)
End-Stage Renal Disease
Related terms Kidney Failure, Chronic
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov