NCT07770477Not yet recruiting
Comparison of Office and Cuffless Ambulatory Blood Pressure-Guided Management in Patients With Hypertension
Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 24 Aug 2026
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Seoul National University Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07770477
What you commit to
- Study type: Interventional
- Planned participants: 3000
- From 24 Aug 2026 to the primary completion date, 31 Dec 2031
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed secondary hypertension.
- Hospitalization for stroke, myocardial infarction (MI) or unstable angina within the last 6 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
- Malignancy history within 5 years.
- Severe cognitive impairment or mental disorders.
Lab values
- 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.
Other
- Did not agree with this clinical trial and did not provide informed consent
- Office SBP ≥ 190 mmHg, or diastolic BP (DBP) \< 60 mmHg.
- 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.
- Participating in other clinical trials other than observation registry
Who the study is looking for
- 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
Age in the registry: 30 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.