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NCT Number: NCT07762859

Wearable Ambulatory Vs. Office BP in Hemodialysis

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.

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Key information

Conditions

ESRD on HD

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • 24-hour mean BP by ambulatory blood pressure monitoring (ABPM): <130/80 mmHg
  • Mean home BP: <135/85 mmHg

Secondary Endpoints

  • Change in mean systolic and diastolic blood pressure
  • Change in blood pressure variability (BPV) parameters, including standard deviation (SD), average real variability (ARV), and dipping pattern
  • Change in total dry weight
  • Change in the number of antihypertensive medications
  • Incidence of adverse events

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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CART BP Pro-guided blood pressure management

Device

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.

Other names: CART BP Pro

Conventional office blood pressure-guided management

Device

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.

Other names: Conventional office blood pressure monitoring

Primary outcomes

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

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

    Out-of-office blood pressure will be assessed at Week 10-11 using standardized Home Blood Pressure Monitoring (HBPM) in all randomized participants and 24-hour Ambulatory Blood Pressure Monitoring (ABPM) in participants enrolled at centers where ABPM is available. Target blood pressure is defined as a mean HBPM of <135/85 mmHg or a 24-hour mean ABPM of <130/80 mmHg, according to the measurement method used. Individual target achievement will be classified as yes or no, and the group-level outcome will range from 0% to 100%. A higher proportion of participants achieving the target indicates better out-of-office blood pressure control. ABPM will be analyzed separately in the prespecified subgroup of participants from ABPM-capable centers.

Secondary outcomes

  1. Change in systolic and diastolic blood pressure

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

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

  2. Change in blood pressure variability

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

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

  3. Change in dry weight

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

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

  4. Change in antihypertensive medication use

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

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

  5. Incidence of treatment-related adverse events

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

    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.

  6. Device-related adverse events

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jong Hyun Jhee, MD, PhD

CONTACT

[email protected]

+82-10-4938-3018

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 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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