Wearable Ambulatory Vs. Office BP in Hemodialysis
ConditionESRD on HD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
CART BP Pro-guided blood pressure management
DeviceParticipants 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 management
DeviceParticipants 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.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Wearable blood pressure-guided managementExperimental treatment 1 intervention
Group B: Conventional office blood pressure-guided managementActive comparator 1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
Week 10-11 (end of study)Secondary outcomes
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.
Time frame
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.
Time frame
(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.
Time frame
(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.
Time frame
(1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)Sponsors and contacts
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Source ClinicalTrials.gov
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