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

N/ANot Yet RecruitingNCT07770477

Seoul National University Hospital3,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,000

Conditions

Hypertension

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (9)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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

Uijeongbu-si, Gyeonggi-do, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Seoul National University Boramae Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: From randomization until the first occurrence of a primary outcome event or the end of follow-up, up to 5 years

Secondary Outcomes

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.