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ESRD on HDNCT07762859

Wearable Ambulatory Vs. Office BP in Hemodialysis

A study testing CART BP Pro-guided blood pressure management and Conventional office blood pressure-guided management in people with ESRD on HD, run by Gangnam Severance Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Hypertension is highly prevalent among patients receiving maintenance hemodialysis and is associated with increased cardiovascular morbidity and mortality. Accurate blood pressure assessment is essential for optimizing dry weight and antihypertensive therapy, but conventional office blood pressure measurements may not… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
ESRD on HD
What is being tested?
CART BP Pro-guided blood pressure management and Conventional office blood pressure-guided management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2026to 30 Oct 2027
Phase
Interventional
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

Who may be able to join

  • Adults aged 19 years or older.
  • Patients receiving hemodialysis three times per week.
  • On maintenance hemodialysis for at least 3 months.
  • Patients with a predialysis blood pressure (BP) of ≥140/90 mmHg measured in the dialysis clinic before study enrollment, or those taking at least one antihypertensive medication.
  • Individuals who provided informed consent to participate in the study.

Who cannot join

  • Presence of an implanted cardiac pacemaker.
  • Patients in whom pulse wave measurement is not feasible due to uncontrolled arrhythmias (e.g., persistent atrial fibrillation).
  • Inability to wear the CART BP Pro device (e.g., due to finger deformity).
  • Life expectancy 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.

Jong Hyun Jhee, MD, PhD contact

+82-10-4938-3018

JJHLOVE77@yuhs.ac

South Korea1 site

  • Gangnam Severance Hospital

    Seoul, 06273

    Jong Hyun Jhee, MD, PhD, +82-10-4938-3018, JJHLOVE77@yuhs.ac

Other trials in South Korea

About this study

Official title: Wearable Ambulatory Versus Office Blood Pressure-Guided Hypertension Management in Hemodialysis Patients: A Multicenter, Single-Blind, Randomized Controlled Trial

Hypertension is highly prevalent among patients receiving maintenance hemodialysis and is associated with increased cardiovascular morbidity and mortality. Accurate blood pressure assessment is essential for optimizing dry weight and antihypertensive therapy, but conventional office blood pressure measurements may not adequately capture the dynamic blood pressure variations that occur throughout the hemodialysis cycle, including the pre-, intra-, post-, and interdialytic periods. Wearable cuffless blood pressure monitoring may provide more comprehensive blood pressure data and facilitate individualized blood pressure management.

The WAVE-HD trial is a prospective, multicenter, single-blind, randomized controlled study designed to compare wearable blood pressure-guided hypertension management using the CART BP Pro device with conventional office blood pressure-guided management in adult patients receiving maintenance hemodialysis. Participants will be randomized in a 1:1 ratio to either the wearable blood pressure-guided management group or the office blood pressure-guided management group. Dry weight and antihypertensive medications will be adjusted according to the assigned blood pressure monitoring strategy. The primary objective of the study is to determine whether wearable blood pressure-guided management increases the proportion of patients achieving target blood pressure compared with conventional office blood pressure-guided management. Secondary outcomes include changes in blood pressure, blood pressure variability, dry weight, antihypertensive medication use, and safety.

Read the detailed description

Design: Prospective, randomized, single-blind, controlled clinical trial

Study duration: Total of 11 weeks after participant enrollment

  • Screening: 1 week
  • Baseline: Week 0
  • Intervention: Weeks 1-9
  • Evaluation: Weeks 10-11

Sample size: A total of 280 participants (140 in the intervention group vs. 140 in the control group)

Intervention

  • Control group: Blood pressure (BP) management based on office (dialysis unit) BP
  • Intervention group: BP management based on wearable/continuous BP monitoring using CART BP Pro

Primary Endpoint: Achievement of target blood pressure

  • Mean home BP: <135/85 mmHg

Secondary Endpoints

  1. 24-hour mean BP by ambulatory blood pressure monitoring (ABPM)
  2. Change in mean systolic and diastolic blood pressure
  3. Change in blood pressure variability (BPV) parameters, including standard deviation (SD), average real variability (ARV), and dipping pattern
  4. Change in total dry weight
  5. Change in the number of antihypertensive medications
  6. Incidence of adverse events
Conditions
ESRD on HD
Being tested
CART BP Pro-guided blood pressure management, Conventional office blood pressure-guided management
Keywords
HD, BP, HTN, Wearable ambulatory BP, ABPM, HBPM, RCT

What participants receive

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

  • CART BP Pro-guided blood pressure managementDevice

    Also called CART BP Pro

    Participants will wear the CART BP Pro cuffless wearable blood pressure monitoring device. Blood pressure data obtained from the device will be used to guide dry weight adjustment and antihypertensive medication titration according to the study protocol. Dry weight will be reduced stepwise when indicated, and antihypertensive medications will be up-titrated or additional agents introduced based on wearable blood pressure measurements, blood pressure patterns (including non-dipping, reverse-dipping, and morning surge), and blood pressure variability. Rescue treatment for hypotension, severe hypertension, or volume overload will be provided according to predefined safety criteria.

  • Conventional office blood pressure-guided managementDevice

    Also called Conventional office blood pressure monitoring

    Participants will also wear the CART BP Pro device; however, blood pressure management will be based on conventional office blood pressure measurements rather than wearable blood pressure data. Dry weight adjustment and antihypertensive medication titration will follow the predefined study algorithm using office blood pressure measurements. Rescue treatment will be identical to that in the experimental group and will be provided according to predefined safety criteria.

Study groups in NCT07762859
Study groupRoleWhat they receive
Wearable blood pressure-guided managementExperimentalParticipants will undergo wearable blood pressure monitoring using the CART BP Pro device. Dry weight and antihypertensive medications will be adjusted according to wearable blood pressure measurements throughout the study.
Receives: Device: CART BP Pro-guided blood pressure management
Conventional office blood pressure-guided managementActive comparatorParticipants will undergo wearable blood pressure monitoring using the CART BP Pro device. However, dry weight and antihypertensive medications will be adjusted according to conventional office blood pressure measurements. Wearable blood pressure data will not be used for treatment decisions.
Receives: Device: Conventional office blood pressure-guided management

What is being measured

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

  1. Achievement of target out-of-office blood pressure

    Description: Out-of-office blood pressure control will be assessed at Week 10-11 using standardized Home Blood Pressure Monitoring (HBPM) in all randomized participants. Target blood pressure will be defined as a mean HBPM of <135/85 mmHg. Individual target achievement will be classified as yes or no, and the group-level outcome will be expressed as the proportion of participants achieving the target, ranging from 0% to 100%. A higher proportion of participants achieving the target indicates better out-of-office blood pressure control.

    Time Frame: Week 10-11 (end of study)

    Measured: Week 10-11 (end of study)

Secondary outcomes (7)

  1. Achievement of Target Blood Pressure Based on 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

    Description: In the prespecified subgroup of participants enrolled at centers where 24-hour Ambulatory Blood Pressure Monitoring (ABPM) is available, out-of-office blood pressure control will additionally be assessed at Week 10-11 using 24-hour ABPM. Target blood pressure will be defined as a 24-hour mean ABPM of <130/80 mmHg. Individual target achievement will be classified as yes or no, and the group-level outcome will be expressed as the proportion of participants achieving the target, ranging from 0% to 100%. A higher proportion of participants achieving the target indicates better ambulatory blood pressure control. ABPM results will be analyzed separately in this prespecified subgroup.

    Measured: Week 10-11 (end of study)

  2. Change in systolic and diastolic blood pressure

    Change in mean systolic and diastolic blood pressure from baseline to Week 10-11.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

  3. Change in blood pressure variability

    Change in blood pressure variability parameters, including standard deviation (SD), average real variability (ARV), and dipping pattern, from baseline to Week 10-11.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

  4. Change in dry weight

    Change in prescribed dry weight from baseline to Week 10-11.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

  5. Change in antihypertensive medication use

    Change in the number of antihypertensive medications from baseline to Week 10-11.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

  6. Incidence of treatment-related adverse events

    Incidence of treatment-related adverse events, including muscle cramps, dizziness, headache, dyspnea, chest discomfort, visual disturbance, orthostatic hypotension, nausea, vomiting, abdominal pain, and intradialytic hypotension.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

  7. Device-related adverse events

    Incidence of device-related adverse events, including skin irritation, pain, device attachment failure, device malfunction, and data loss associated with use of the CART BP Pro device.

    Measured: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)

Timeline

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

  1. First posted13 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to either the wearable blood pressure-guided management group or the conventional office blood pressure-guided management group. Dry weight and antihypertensive medications will be adjusted according to the assigned blood pressure monitoring strategy throughout the study.
Masking
Single blind
Who is masked
Participant
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07762859
Sponsor's protocol ID
3-2026-0245
Status last verified
Sep 2026
First submitted
10 Aug 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant-level data will not be routinely shared during the conduct of the study. Decisions regarding future sharing of de-identified individual participant data with external researchers will be made after completion of the study and publication of the primary results, in accordance with institutional policies, applicable regulations, and approval by the study steering committee.

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?

A study testing CART BP Pro-guided blood pressure management and Conventional office blood pressure-guided management in people with ESRD on HD, 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Sep 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?

Contact Jong Hyun Jhee, MD, PhD (+82-10-4938-3018, JJHLOVE77@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of target out-of-office blood pressure (time frame: Week 10-11 (end of study)). 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 NCT07762859, 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 9 Sep 2026.

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