HypertensionCUFFLESSNCT07770477
Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension
A study testing Cuffless ambulatory blood pressure-guided management and Office blood pressure-guided management in people with Hypertension, run by Seoul National University Hospital at 9 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cuffless ambulatory blood pressure-guided management and Office blood pressure-guided management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 24 Aug 2026to 31 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites
Kyungpook National University Hospital
Daegu
Jang Hoon Lee, MD, PhD, 82-53-200-6414, ljhmh75@knu.ac.kr
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Kwang-Il Kim, MD, PhD, 82-31-787-7032, kikim907@gmail.com
Korea University Anam Hospital
Seoul
Hyung Joon Joo, MD, PhD, 82-2-2286-1214, drjoohj@gmail.com
Korea University Guro Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Il-Suk Sohn, MD, PhD, 82-10-8772-4662, issohn@khu.ac.kr
Seoul National University Boramae Medical Center
Seoul
Hack-Lyoung Kim, MD, PhD, 82-2-870-3235, khl2876@gmail.com
Seoul National University Hospital
Seoul
Hae-Young Lee, MD, PhD, 82-10-4528-6160, hylee612@snu.ac.kr
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Woo-Baek Chung, MD, PhD, 82-2-2258-1134, peace816@catholic.ac.kr
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do
Hyo-Suk Ahn, MD, PhD, 82-10-4223-9201, alaco0502@gmail.com
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Cuffless ambulatory blood pressure-guided management, Office blood pressure-guided management
- Keywords
- Cuffless Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffless ambulatory blood pressure-guided managementOther
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 managementOther
Participants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of <140 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Cuffless ambulatory blood pressure-guided management group | Experimental | 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. Receives: Other: Cuffless ambulatory blood pressure-guided management |
| Office blood pressure-guided management group | Active comparator | Participants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements. Receives: Other: Office blood pressure-guided management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with new cardiovascular events
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.
Measured: From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years
Secondary outcomes (10)
Number of participants with death due to cardiovascular causes
Occurrence of death due to cardiovascular causes, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of nonfatal stroke, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of myocardial infarction, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of coronary revascularization, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of acute decompensated heart failure, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of unstable angina with hospitalization, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of chronic kidney disease, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of atrial fibrillation, analyzed as an individual component of the primary composite outcome.
Measured: 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
Occurrence of left ventricular hypertrophy, analyzed as an individual component of the primary composite outcome.
Measured: 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
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.
Measured: From randomization through the end of follow-up, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Hypertension
- Responsible party
- Principal investigator, Hae-young Lee, Seoul National University Hospital
- Investigators
- Hae-Young Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770477
- Sponsor's protocol ID
- CUFFLESS
- Acronym
- CUFFLESS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07770477
- Acronym / sponsor ID
- CUFFLESS / CUFFLESS
- Conditions
- Hypertension
- Keywords
- Cuffless Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Hypertension
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuffless ambulatory blood pressure-guided management group | Experimental | Other: Cuffless ambulatory blood pressure-guided managementParticipants 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. |
| Office blood pressure-guided management group | Active comparator | Other: Office blood pressure-guided managementParticipants assigned to this group will receive conventional hypertension management guided by office blood pressure measurements. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuffless ambulatory blood pressure-guided managementParticipants 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. | Other | Cuffless ambulatory blood pressure-guided management group |
| Office blood pressure-guided managementParticipants will receive conventional hypertension management guided by office blood pressure measurements, with a target office systolic blood pressure of <140 mmHg. | Other | Office blood pressure-guided management group |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
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
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
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
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
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
Win ratio for the hierarchical composite outcome
Time frame: From randomization through the end of follow-up, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hae-Young Lee, MD, PhD principal investigator
Seoul National University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuffless ambulatory blood pressure-guided management and Office blood pressure-guided management in people with Hypertension, run by Seoul National University Hospital at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Young Yoon (82-10-2704-4542, seecross2846@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.