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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
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.
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.
Gangnam Severance Hospital
Seoul, South Korea
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)
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)
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)
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)
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)
Change in antihypertensive medication use
Change in the number of antihypertensive medications 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)
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.
Time frame: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)
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.
Time frame: (1~4) Baseline to Week 10-11 (5~6) Throughout the study (Baseline to Week 10-11)
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