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.
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
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
Parallel
Cuffless ambulatory blood pressure-guided management
Other interventionParticipants 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 interventionParticipants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of \<140 mmHg.
Number of participants with new cardiovascular events
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.
Number of participants with death due to cardiovascular causes
Occurrence of death due to cardiovascular causes, analyzed as an individual component of the primary composite outcome.
Number of participants with nonfatal stroke
Occurrence of nonfatal stroke, analyzed as an individual component of the primary composite outcome.
Number of participants with myocardial infarction
Occurrence of myocardial infarction, analyzed as an individual component of the primary composite outcome.
Number of participants with coronary revascularization
Occurrence of coronary revascularization, analyzed as an individual component of the primary composite outcome.
Long-Term Cardiovascular Outcomes During Extended Follow-up
Long-term occurrence of the composite cardiovascular outcome, defined as 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, will be assessed using administrative claims and other available follow-up data.
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Seoul National University Hospital
Lead sponsor
Korean Society of Hypertension
Collaborator
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