Cuffless BP Monitoring in Hemodialysis

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.

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Key information

Conditions

ESRD on HD Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CART BP pro

Device

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.

Other names: Cuffless Blood Pressure Monitoring Device

Primary outcomes

Reproducibility and agreement of CART BP Pro measurements

Time frame: At baseline (first study dialysis session) and at 6 and 12 months after the baseline assessment

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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Evaluation of Cuffless Blood Pressure Monitoring in Hemodialysis (CURE-HD) Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 10, 2026
Registry last updated: Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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