Hypertension
Conditions
Keywords
Cuffless Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring
Brief 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.
Interventions
OTHERCuffless 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.
OTHEROffice 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.
Sponsors
Seoul National University Hospital
Korean Society of Hypertension
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The trial is open-label to participants, care providers, and investigators. Clinical outcome events will be adjudicated by an independent Event Adjudication Committee blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) within the last 12 months. * Planned to perform coronary revascularization (PCI or CABG) in the next 12 months. * History of sustained atrial fibrillation (AF) or ventricular arrhythmias at entry influencing the BP measurement of ring-type cuffless BP monitoring device. * Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial. * Underlying heart disease: Hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), rheumatic heart disease or congenital heart disease * Uncontrolled diabetes mellitus (serum fasting glucose \> 200 mg/dL or glycated hemoglobin \[HbA1c\] \>8%). * Severe liver dysfunction (alanine aminotransferase \[ALT\] \> 3 times the upper limit of normal (ULN) value). * Severe renal dysfunction (end stage renal disease \[ESRD\] on dialysis or estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73m², or serum creatinine \>2.5 mg/dL. * Malignancy history within 5 years. * Severe cognitive impairment or mental disorders. * Participating in other clinical trials other than observation registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with death due to cardiovascular causes | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of death due to cardiovascular causes, analyzed as an individual component of the primary composite outcome. |
| Number of participants with nonfatal stroke | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of nonfatal stroke, analyzed as an individual component of the primary composite outcome. |
| Number of participants with myocardial infarction | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of myocardial infarction, analyzed as an individual component of the primary composite outcome. |
| Number of participants with coronary revascularization | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of coronary revascularization, analyzed as an individual component of the primary composite outcome. |
| Number of participants with acute decompensated heart failure | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of acute decompensated heart failure, analyzed as an individual component of the primary composite outcome. |
| Number of participants with unstable angina with hospitalization | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of unstable angina with hospitalization, analyzed as an individual component of the primary composite outcome. |
| Number of participants with chronic kidney disease | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of chronic kidney disease, analyzed as an individual component of the primary composite outcome. |
| Number of participants with atrial fibrillation | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of atrial fibrillation, analyzed as an individual component of the primary composite outcome. |
| Number of participants with left ventricular hypertrophy | From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years | Occurrence of left ventricular hypertrophy, analyzed as an individual component of the primary composite outcome. |
| Win ratio for the hierarchical composite outcome | From randomization through the end of follow-up, up to 5 years | The hierarchical composite outcome will be analyzed using the win ratio approach, prioritizing events in the following order of clinical importance: (1) death due to cardiovascular causes; (2) nonfatal stroke, myocardial infarction, or acute decompensated heart failure; (3) unstable angina with hospitalization; and (4) coronary revascularization, chronic kidney disease, atrial fibrillation, or left ventricular hypertrophy. |
Countries
South Korea
Contacts
CONTACTJi Young Yoon
CONTACTSeung-Mok Lee, MD
PRINCIPAL_INVESTIGATORHae-Young Lee, MD, PhD
Seoul National University Hospital
Outcome results
None listed