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

Sponsor
Seoul National University Hospital
Study ID
NCT07770477
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Cuffless ambulatory blood pressure-guided management — OTHER
    Participants will undergo 24-hour ambulatory blood pressure monitoring using a cuffless blood pressure monitoring device at least annually. Antihypertensive treatment will be adjusted based on both office and cuffless ambulatory blood pressure measurements, with target systolic blood pressure values of \<140 mmHg for office BP, \<135 mmHg for daytime mean BP, \<120 mmHg for nighttime mean BP, and \<130 mmHg for 24-hour mean BP.
  • Office blood pressure-guided management — OTHER
    Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of \<140 mmHg.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 24, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2036

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cuffless ambulatory blood pressure-guided management group
    Participants assigned to this group will receive hypertension management guided by both office blood pressure and 24-hour ambulatory blood pressure measured using a cuffless BP monitoring device.
  • Active Comparator: Office blood pressure-guided management group
    Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.

Primary Outcome Measure

Number of participants with new cardiovascular events [ Time Frame: From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years ]

Central Contacts

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