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Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension
Sponsor: Seoul National University Hospital
Summary
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.
Official title: Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
Key Details
Gender
All
Age Range
30 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
3000
Start Date
2026-08-24
Completion Date
2036-12-31
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Cuffless ambulatory blood pressure-guided management
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
Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of \<140 mmHg.
Locations (9)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea