An interventional study of CART BP Pro-guided blood pressure management and Conventional office blood pressure-guided management in ESRD on HD, sponsored by Gangnam Severance Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment
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
Sample size: A total of 280 participants (140 in the intervention group vs. 140 in the control group)
Intervention
Primary Endpoint: Achievement of target blood pressure
- Mean home BP: \<135/85 mmHg
Secondary Endpoints
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 280 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Gangnam Severance Hospital is the lead sponsor of 146 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Device: CART BP Pro-guided blood pressure management
Participants 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.
Device: Conventional office blood pressure-guided 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.
Also known as: CART BP Pro
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.
Also known as: Conventional office blood pressure monitoring
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)
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 10 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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