Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension (CUFFLESS)
17 de agosto de 2026 actualizado por: Hae-young Lee, Seoul National University Hospital
Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
3000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ji Young Yoon
- Número de teléfono: 82-10-2704-4542
- Correo electrónico: seecross2846@snu.ac.kr
Copia de seguridad de contactos de estudio
- Nombre: Seung-Mok Lee, MD
- Número de teléfono: 82-10-7185-4340
- Correo electrónico: mokmom@snu.ac.kr
Ubicaciones de estudio
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Daegu, Corea del Sur
- Kyungpook National University Hospital
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Contacto:
- Jang Hoon Lee, MD, PhD
- Número de teléfono: 82-53-200-6414
- Correo electrónico: ljhmh75@knu.ac.kr
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Seoul, Corea del Sur
- Korea University Anam Hospital
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Contacto:
- Hyung Joon Joo, MD, PhD
- Número de teléfono: 82-2-2286-1214
- Correo electrónico: drjoohj@gmail.com
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Seoul, Corea del Sur
- Korea University Guro Hospital
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Seoul, Corea del Sur
- Seoul National University Hospital
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Contacto:
- Hae-Young Lee, MD, PhD
- Número de teléfono: 82-10-4528-6160
- Correo electrónico: hylee612@snu.ac.kr
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Seoul, Corea del Sur
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Contacto:
- Woo-Baek Chung, MD, PhD
- Número de teléfono: 82-2-2258-1134
- Correo electrónico: peace816@catholic.ac.kr
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Seoul, Corea del Sur
- Seoul National University Boramae Medical Center
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Contacto:
- Hack-Lyoung Kim, MD, PhD
- Número de teléfono: 82-2-870-3235
- Correo electrónico: khl2876@gmail.com
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Seoul, Corea del Sur
- Kyung Hee University Hospital at Gangdong
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Contacto:
- Il-Suk Sohn, MD, PhD
- Número de teléfono: 82-10-8772-4662
- Correo electrónico: issohn@khu.ac.kr
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sur
- Seoul National University Bundang Hospital
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Contacto:
- Kwang-Il Kim, MD, PhD
- Número de teléfono: 82-31-787-7032
- Correo electrónico: kikim907@gmail.com
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Uijeongbu-si, Gyeonggi-do, Corea del Sur
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
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Contacto:
- Hyo-Suk Ahn, MD, PhD
- Número de teléfono: 82-10-4223-9201
- Correo electrónico: alaco0502@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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Comparador activo: Office blood pressure-guided management group
Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.
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Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of <140 mmHg.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with new cardiovascular events
Periodo de tiempo: From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
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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.
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From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with death due to cardiovascular causes
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of death due to cardiovascular causes, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Number of participants with nonfatal stroke
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of nonfatal stroke, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Number of participants with myocardial infarction
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of myocardial infarction, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Number of participants with coronary revascularization
Periodo de tiempo: 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.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with acute decompensated heart failure
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of acute decompensated heart failure, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with unstable angina with hospitalization
Periodo de tiempo: 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.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with chronic kidney disease
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of chronic kidney disease, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Number of participants with atrial fibrillation
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of atrial fibrillation, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
|
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Number of participants with left ventricular hypertrophy
Periodo de tiempo: From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Occurrence of left ventricular hypertrophy, analyzed as an individual component of the primary composite outcome.
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From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
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Win ratio for the hierarchical composite outcome
Periodo de tiempo: From randomization through the end of follow-up, up to 5 years
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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.
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From randomization through the end of follow-up, up to 5 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Long-Term Cardiovascular Outcomes During Extended Follow-up
Periodo de tiempo: From randomization through the end of extended follow-up, up to 10 years
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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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From randomization through the end of extended follow-up, up to 10 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hae-Young Lee, MD, PhD, Seoul National University Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de agosto de 2026
Finalización primaria (Estimado)
31 de diciembre de 2031
Finalización del estudio (Estimado)
31 de diciembre de 2036
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
18 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CUFFLESS
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .