Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-79
SponsorSeoul National University Hospital

About this trial

Hypertension is a major risk factor for cardiovascular and cerebrovascular diseases, including stroke and myocardial infarction. Blood pressure (BP) fluctuates throughout the day in response to physical activity, emotional states, and sleep. However, hypertension diagnosis and management are commonly based on BP measurements obtained in the clinic or at home, which may not fully reflect these variations. This can contribute to discrepancies between office and out-of-office BP, including white-coat and masked hypertension.

Ambulatory blood pressure monitoring (ABPM) provides information on BP throughout daily activities and sleep, but conventional cuff-based ABPM may be limited by discomfort, accessibility, and logistical challenges. Recently, cuffless wearable devices have enabled repeated BP monitoring without the use of a conventional inflatable cuff.

The CUFFLESS study is a multicenter, prospective, randomized controlled trial comparing two strategies for the management of hypertension: cuffless ambulatory BP-guided management and conventional office BP-guided management. Participants will be randomly assigned to either management strategy and followed for clinical outcomes. The primary objective is to determine whether hypertension management guided by cuffless ambulatory BP monitoring reduces the occurrence of cardiovascular events compared with management guided by conventional office BP measurements.

Eligibility criteria

Qualifiers

24 hour mean SBP ≥ 130 mmHg by cuffless ambulatory BP monitor

aged ≥30 and <80 years

voluntarily decide to participate in this clinical trial and provide written informed consent after being adequately informed.

willing and able to comply with the requirements of the study protocol

Disqualifiers

Did not agree with this clinical trial and did not provide informed consent

Office SBP ≥ 190 mmHg, or diastolic BP (DBP) < 60 mmHg.

Diagnosed secondary hypertension.

Hospitalization for stroke, myocardial infarction (MI) or unstable angina within the last 6 months

Trial design

Treatments tested in this trial

  • Cuffless ambulatory blood pressure-guided management
  • Office blood pressure-guided management

Treatment groups

3,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seoul National University Hospital

Lead sponsor

Korean Society of Hypertension

Collaborator