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NCT Number: NCT07770477

Comparison of 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cuffless ambulatory blood pressure-guided management

Other

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.

Office blood pressure-guided management

Other

Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of <140 mmHg.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Young Yoon

CONTACT

[email protected]

82-10-2704-4542

Seung-Mok Lee, MD

CONTACT

[email protected]

82-10-7185-4340

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korean Society of Hypertension

Registry information

Official study title

Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension

Acronym: CUFFLESS

Important dates

Study start
2026
Primary completion
2031
Study completion
2036
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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