Home Blood Pressure Intervention in the Community Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Composite of adverse cardiovascular events
研究概览
简要总结
The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.
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
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60-80 years old
- •Have been taking antihypertensive drugs for more than 2 weeks
- •The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
- •Willing to participate, adhere to follow-up, and sign the written informed consent form
排除标准
- •Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
- •Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
- •Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
- •Suspected or known secondary hypertension
- •Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
- •eGFR<30 ml/min/1.73m2 or end-stage renal disease
- •Cardiovascular events occured within the past 3 months, such as myocardial infarction, stroke, acute heart failure, hospitalization for unstable angina, undergoing coronary artery revascularization or bypass grafting
- •Abnormal liver function (ALT/AST/total bilirubin more than 2 times the upper limit of normal value)
- •Severe somatic disease with a life expectancy of less than 3 years, or diagnosed with cancer within the past 2 years requiring treatment
- •Doctors deem that the participation would do harm to the patients or the patients would have poor compliance.
研究组 & 干预措施
Intensive Home BP Control
Participants randomized into the intensive treatment arm will have a goal of home BP<125/75 mmHg.
干预措施: Intensive Home BP control (Drug)
Standard Home BP Control
Participants randomized into the standard treatment arm will have a goal of home BP within 125-134/75-84 mmHg.
干预措施: Standard Home BP control (Drug)
结局指标
主要结局
Composite of adverse cardiovascular events
时间窗: 48 months
Composite of major adverse cardiovascular events consisting of death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass grafting \[CABG\]), hospitalization for heart failure or unstable agina.
次要结局
- Renal outcome(48 months)
- Adverse or severe adverse events(48 months)
- Components of the primary outcome(48 months)
研究者
Yan Li
Professor, Doctor of Medicine, Doctor of Philosophy
Shanghai Institute of Hypertension