Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants with new cardiovascular events — From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
New cardiovascular events, defined as a composite of death due to cardiovascular causes, nonfatal stroke, myocardial infarction, acute decompensated heart failure, unstable angina with hospitalization, coronary revascularization, chronic kidney disease, atrial fibrillation and left ventricular hypertrophy.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | |
| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Uijeongbu-si | Gyeonggi-do | |
| 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 |
More Seoul National University Hospital trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07770477 on ClinicalTrials.gov ↗ ← All trials in South Korea