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

2026年8月17日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

3000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Seung-Mok Lee, MD
  • 电话号码：82-10-7185-4340
  • 邮箱：mokmom@snu.ac.kr

学习地点

  • 韩国
      • Daegu、韩国
        • Kyungpook National University Hospital
        • 接触：
      • Seoul、韩国
        • Korea University Anam Hospital
        • 接触：
      • Seoul、韩国
        • Korea University Guro Hospital
      • Seoul、韩国
        • Seoul National University Hospital
        • 接触：
      • Seoul、韩国
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • 接触：
      • Seoul、韩国
        • Seoul National University Boramae Medical Center
        • 接触：
      • Seoul、韩国
        • Kyung Hee University Hospital at Gangdong
        • 接触：
    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、韩国
        • Seoul National University Bundang Hospital
        • 接触：
      • Uijeongbu-si、Gyeonggi-do、韩国
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：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.
有源比较器：Office blood pressure-guided management group
Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants with new cardiovascular events
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Number of participants with death due to cardiovascular causes
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Long-Term Cardiovascular Outcomes During Extended Follow-up
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Seoul National University Hospital

合作者

Korean Society of Hypertension

调查人员

  • 首席研究员：Hae-Young Lee, MD, PhD、Seoul National University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月24日

初级完成 (估计的)

2031年12月31日

研究完成 (估计的)

2036年12月31日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CUFFLESS

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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