Comparison of Clinical Outcomes Between Office and Cuffless Ambulatory Blood Pressure-guided Management in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 9
- 主要终点
- Number of participants with new cardiovascular events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with new cardiovascular events
时间窗: 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.
次要结局
- 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)
- Number of participants with unstable angina with hospitalization(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(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(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(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(From randomization through the end of follow-up, up to 5 years)
研究者
Hae-young Lee
Chief, Cardiovascular division, Seoul National University Hospital
Seoul National University Hospital