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

August 17, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Active Comparator: Office blood pressure-guided management group
Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with new cardiovascular events
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with death due to cardiovascular causes
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-Term Cardiovascular Outcomes During Extended Follow-up
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korean Society of Hypertension

Investigators

  • Principal Investigator: Hae-Young Lee, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2036

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUFFLESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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