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NCT07762859Not yet recruiting

Wearable Ambulatory Vs. Office BP in Hemodialysis

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
280 (estimated)
First submitted
10 Aug 2026
Start date
Sept 2026
Primary completion date
Jul 2027
Lead sponsor
Gangnam Severance Hospital
NCT number
NCT07762859

What you commit to

  • Study type: Interventional
  • Planned participants: 280
  • From Sept 2026 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of an implanted cardiac pacemaker.
  • Patients in whom pulse wave measurement is not feasible due to uncontrolled arrhythmias (e.g., persistent atrial fibrillation).

Other

  • Inability to wear the CART BP Pro device (e.g., due to finger deformity).
  • Life expectancy of less than 6 months.

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gangnam Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.