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End-Stage Renal DiseaseNCT07753876

Cuffless BP Monitoring in Hemodialysis

An observational study of End-Stage Renal Disease, run by Gangnam Severance Hospital at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
End-Stage Renal Disease
What is being tested?
CART BP Pro
Type of treatment
Medical device
How many people
240 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2025to 1 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Gangnam Severance Hospital

    Seoul, 06273

Other trials in South Korea

About this study

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

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.

Being tested
CART BP Pro
Keywords
Hemodialysis, ESRD, Cuffless Blood Pressure, CART BP Pro, ABPM, Blood Pressure Variability, CURE-HD
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CART BP ProDevice

    Also called Cuffless Blood Pressure Monitoring 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.

Study groups in NCT07753876
Study groupRoleWhat they receive
Maintenance Hemodialysis PatientsAdult 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.
Receives: Device: CART BP Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start1 Jul 2025
  3. Primary completion1 Aug 2026
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753876
Sponsor's protocol ID
3-2025-0137
Status last verified
Aug 2026
First submitted
20 Aug 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38225785

  • 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.

    PubMed 16344376

  • 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.

    PubMed 24700870

  • 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.

    PubMed 40811497

  • 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.

    PubMed 28340239

  • 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.

    PubMed 32278617

Questions about this trial

What is this clinical trial studying?

An observational study of End-Stage Renal Disease, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07753876, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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