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

Qualifiers

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

Treatments tested in this trial

  • CART BP Pro-guided blood pressure management
  • Conventional office blood pressure-guided management

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators