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Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension (CUFFLESS)

17 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

3000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Seung-Mok Lee, MD
  • Número de telefone: 82-10-7185-4340
  • E-mail: mokmom@snu.ac.kr

Locais de estudo

  • Coréia do Sul
      • Daegu, Coréia do Sul
        • Kyungpook National University Hospital
        • Contato:
          • Jang Hoon Lee, MD, PhD
          • Número de telefone: 82-53-200-6414
          • E-mail: ljhmh75@knu.ac.kr
      • Seoul, Coréia do Sul
        • Korea University Anam Hospital
        • Contato:
          • Hyung Joon Joo, MD, PhD
          • Número de telefone: 82-2-2286-1214
          • E-mail: drjoohj@gmail.com
      • Seoul, Coréia do Sul
        • Korea University Guro Hospital
      • Seoul, Coréia do Sul
        • Seoul National University Hospital
        • Contato:
      • Seoul, Coréia do Sul
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contato:
      • Seoul, Coréia do Sul
        • Seoul National University Boramae Medical Center
        • Contato:
          • Hack-Lyoung Kim, MD, PhD
          • Número de telefone: 82-2-870-3235
          • E-mail: khl2876@gmail.com
      • Seoul, Coréia do Sul
        • Kyung Hee University Hospital at Gangdong
        • Contato:
          • Il-Suk Sohn, MD, PhD
          • Número de telefone: 82-10-8772-4662
          • E-mail: issohn@khu.ac.kr
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Coréia do Sul
        • Seoul National University Bundang Hospital
        • Contato:
      • Uijeongbu-si, Gyeonggi-do, Coréia do Sul
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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.
Comparador Ativo: Office blood pressure-guided management group
Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of participants with new cardiovascular events
Prazo: 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.
From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants with death due to cardiovascular causes
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with nonfatal stroke
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with myocardial infarction
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with coronary revascularization
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with acute decompensated heart failure
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with unstable angina with hospitalization
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with chronic kidney disease
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with atrial fibrillation
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Number of participants with left ventricular hypertrophy
Prazo: 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.
From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years
Win ratio for the hierarchical composite outcome
Prazo: 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.
From randomization through the end of follow-up, up to 5 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Long-Term Cardiovascular Outcomes During Extended Follow-up
Prazo: From randomization through the end of extended follow-up, up to 10 years
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.
From randomization through the end of extended follow-up, up to 10 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Seoul National University Hospital

Colaboradores

Korean Society of Hypertension

Investigadores

  • Investigador principal: Hae-Young Lee, MD, PhD, Seoul National University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de agosto de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2031

Conclusão do estudo (Estimado)

31 de dezembro de 2036

Datas de inscrição no estudo

Enviado pela primeira vez

11 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de agosto de 2026

Primeira postagem (Real)

18 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CUFFLESS

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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