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

NCT07770477 | Not Yet Recruiting DMC

• 1 other identifier: CUFFLESS
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 9

Brief 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. 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

Keywords

Cuffless Blood Pressure Monitoring; Ambulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  From randomization until the occurrence of the respective outcome or the end of follow-up, up to 5 years

Other Outcomes (1)

• Long-Term Cardiovascular Outcomes During Extended Follow-up

  From randomization through the end of extended follow-up, up to 10 years

Study Arms (2)

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.

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.

Other: Office blood pressure-guided management

Interventions

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.

Cuffless ambulatory blood pressure-guided management group

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.

Office blood pressure-guided management group

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Society of Hypertension: collaborator
• Seoul National University Hospital: lead

Study Sites (9)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hae-Young Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Young Yoon

CONTACT

82-10-2704-4542; seecross2846@snu.ac.kr

Seung-Mok Lee, MD

CONTACT

82-10-7185-4340; mokmom@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial is open-label to participants, care providers, and investigators. Clinical outcome events will be adjudicated by an independent Event Adjudication Committee blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiovascular division, Seoul National University Hospital

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 18, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2036
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

KR (9)