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Enrolling By Invitation
NCT07753876
Cuffless BP Monitoring in Hemodialysis
Conditions: ESRD on HD
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 240
Sponsor: Gangnam Severance Hospital
Location: Gangnam Severance Hospital Seoul
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07753876). StuddyBuddy aggregates publicly available trial information.