ESRD on HD
Conditions
Keywords
HD, BP, HTN, Wearable ambulatory BP, ABPM, HBPM, RCT
Brief 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 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.
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
Interventions
DEVICECART BP Pro-guided blood pressure management
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.
DEVICEConventional office blood pressure-guided management
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants and outcome assessors will be blinded to treatment allocation throughout the study. Both groups will wear the CART BP Pro device, and participants will not be informed whether blood pressure management is guided by wearable blood pressure monitoring or conventional office blood pressure measurements. Allocation concealment will be maintained using sequentially numbered, sealed envelopes prepared according to a computer-generated block randomization schedule. Treating investigators responsible for dry weight and antihypertensive medication adjustment will not be blinded to group assignment. Statistical analyses will be performed by statisticians who remain blinded to treatment allocation until completion of the primary analysis.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of target out-of-office blood pressure | Week 10-11 (end of study) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Target Blood Pressure Based on 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | Week 10-11 (end of study) | 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. |
| Change in systolic and diastolic blood pressure | (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. |
| Change in blood pressure variability | (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. |
| Change in dry weight | (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. |
| Change in antihypertensive medication use | (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. |
| Incidence of treatment-related adverse events | (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. |
| Device-related adverse events | (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. |
Countries
South Korea
Contacts
CONTACTJong Hyun Jhee, MD, PhD
Outcome results
None listed