Cuffless BP Monitoring in Hemodialysis

NCT07753876 | Enrolling By Invitation

• 1 other identifier: 3-2025-0137
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemodialysis; ESRD; Cuffless Blood Pressure; CART BP Pro; ABPM; Blood Pressure Variability; CURE-HD

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Maintenance Hemodialysis Patients

Adult patients (≥19 years) receiving maintenance hemodialysis for at least 3 months who meet the eligibility criteria. Participants will undergo cuffless blood pressure monitoring using the CART BP Pro device, conventional pre-dialysis blood pressure measurement, and 24-hour ambulatory blood pressure monitoring according to the study protocol. Blood pressure variability, measurement reproducibility, cardiovascular parameters, and clinical outcomes will be prospectively evaluated over a 12-month follow-up.

Device: CART BP Pro

Interventions

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.

Also known as: Cuffless Blood Pressure Monitoring Device

Maintenance Hemodialysis Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving maintenance hemodialysis for at least 3 months at Gangnam Severance Hospital, Yongin Severance Hospital, and Catholic Kwandong University International St. Mary's Hospital in South Korea will be screened for eligibility. Patients who meet the inclusion and exclusion criteria and provide written informed consent will be prospectively enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Related Publications (6)

• Kim J, Chang SA, Park SW. First-in-Human Study for Evaluating the Accuracy of Smart Ring Based Cuffless Blood Pressure Measurement. J Korean Med Sci. 2024 Jan 15;39(2):e18. doi: 10.3346/jkms.2024.39.e18.

  PMID: 38225785 BACKGROUND

• Agarwal R, Brim NJ, Mahenthiran J, Andersen MJ, Saha C. Out-of-hemodialysis-unit blood pressure is a superior determinant of left ventricular hypertrophy. Hypertension. 2006 Jan;47(1):62-8. doi: 10.1161/01.HYP.0000196279.29758.f4. Epub 2005 Dec 12.

  PMID: 16344376 BACKGROUND

• Agarwal R, Flynn J, Pogue V, Rahman M, Reisin E, Weir MR. Assessment and management of hypertension in patients on dialysis. J Am Soc Nephrol. 2014 Aug;25(8):1630-46. doi: 10.1681/ASN.2013060601. Epub 2014 Apr 3.

  PMID: 24700870 BACKGROUND

• Writing Committee Members*; Jones DW, Ferdinand KC, Taler SJ, Johnson HM, Shimbo D, Abdalla M, Altieri MM, Bansal N, Bello NA, Bress AP, Carter J, Cohen JB, Collins KJ, Commodore-Mensah Y, Davis LL, Egan B, Khan SS, Lloyd-Jones DM, Melnyk BM, Mistry EA, Ogunniyi MO, Schott SL, Smith SC Jr, Talbot AW, Vongpatanasin W, Watson KE, Whelton PK, Williamson JD. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Sep 16;152(11):e114-e218. doi: 10.1161/CIR.0000000000001356. Epub 2025 Aug 14.

  PMID: 40811497 BACKGROUND

• Sarafidis PA, Persu A, Agarwal R, Burnier M, de Leeuw P, Ferro CJ, Halimi JM, Heine GH, Jadoul M, Jarraya F, Kanbay M, Mallamaci F, Mark PB, Ortiz A, Parati G, Pontremoli R, Rossignol P, Ruilope L, Van der Niepen P, Vanholder R, Verhaar MC, Wiecek A, Wuerzner G, London GM, Zoccali C. Hypertension in dialysis patients: a consensus document by the European Renal and Cardiovascular Medicine (EURECA-m) working group of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) and the Hypertension and the Kidney working group of the European Society of Hypertension (ESH). Nephrol Dial Transplant. 2017 Apr 1;32(4):620-640. doi: 10.1093/ndt/gfw433.

  PMID: 28340239 BACKGROUND

• Flythe JE, Chang TI, Gallagher MP, Lindley E, Madero M, Sarafidis PA, Unruh ML, Wang AY, Weiner DE, Cheung M, Jadoul M, Winkelmayer WC, Polkinghorne KR; Conference Participants. Blood pressure and volume management in dialysis: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2020 May;97(5):861-876. doi: 10.1016/j.kint.2020.01.046. Epub 2020 Mar 8.

  PMID: 32278617 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

An additional 5 mL of whole blood (one EDTA tube) will be collected during routine pre-dialysis blood sampling. Plasma samples will be stored for exploratory analyses of biomarkers associated with blood pressure regulation and cardiorenal outcomes in hemodialysis patients (e.g., NT-proBNP, hs-cTnT, galectin-3, inflammatory cytokines, and endothelin-1)

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 10, 2026
• Study Start: July 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

KR (1)