Effects of Intensive Systolic Blood Pressure Lowering Treatment on Out-of-office Blood Pressure - an Ancillary Study to Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Differences of the mean blood pressure during daytime
研究概览
简要总结
This study aims to evaluate the effect of intensive treatment (a target clinic based systolic blood pressure(BP) <120mmHg) on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension, compared with standard treatment (a target clinic based systolic BP <140mmHg).
详细描述
This study aims to evaluate the effect of intensive treatment (a target clinic based systolic BP <120mmHg) on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension, compared with standard treatment (a target clinic based systolic BP <140mmHg). The population of this study is from an ongoing multi-centre open label clinical trial which evaluated the effect of intensive systolic hypertension treatment on major cardiac events (ESPRIT study). ESPRIT study enrolled patients with high risk of cardiovascular disease, who were aged≥50 years old with a systolic BP≥130 mmHg, and assigned them randomly to intense hypertension group (a target clinic based systolic BP <120mmHg) or standard hypertension group (a target clinic based systolic BP <140mmHg), with a 3-year follow-up, evaluating the effect of intense hypertension treatment on major cardiac events.
From those eligible ones for the trial, the investigators plan to select 710 to participate in this study. During the 2-3 years of follow-up of the main trial, the participants will be monitored using 24-hour ambulatory blood pressure monitoring, meanwhile one-week home blood pressure monitoring will also be conducted. The two monitoring approaches will be performed twice; once every half year, based on which this study will evaluate the effect of intensive hypertension treatment on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible for the follow up of the main study;
- •content to participate in the sub-study.
排除标准
- •frequently working during night-time;
- •the non - dominant arm could not wear 24-hour ambulatory blood pressure monitoring due to radiation therapy or physical impairment;
- •keep engaged in out-door activities of high physical intensity, e.g. farming or porter, etc.;
- •life expectancy is less than 1 year; such as diagnosed with heart failure, cancer, or end-stage renal disease;
- •the difference of clinical systolic pressure between upper arms was more than 10 mmHg;
- •unable to use smart-phone to upload family blood pressure monitoring data.
研究组 & 干预措施
Intensive BP Arm
Participants randomized into the Intensive treatment group will have a goal of SBP <120 mmHg. A two- or three-drug regimen should be initiated at randomization for most participants. Drug doses should be increased and/or additional antihypertensive medications should be added at each visit in the intensive treatment group, usually at monthly intervals, until the participant's goal of <120 mmHg has been reached or the local investigator decides no further antihypertensive medications may be added.
干预措施: Intensive BP Arm (Drug)
Standard BP Arm
Participants randomized into the Standard treatment group will have a goal of SBP <140 mmHg. It is expected to achieve a SBP of 135-139 mmHg in as many participants as possible. Medication dose titration or addition of another drug is indicated if SBP is ≥160 mmHg at a single visit or is ≥140 mmHg at two consecutive visits. Down titration should be carried out if the SBP is <130 mmHg at a single visit or <135 mmHg at two consecutive visits.
干预措施: Standard BP Arm (Drug)
结局指标
主要结局
Differences of the mean blood pressure during daytime
时间窗: During the 2-3 years of follow-up of the main trial (ESPRIT)
During the 2-3 years of follow-up of the main trial, to compare the differences of the mean blood pressure during daytime among different intervention groups
次要结局
- Proportion of participants with Masked uncontrolled hypertension(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of the proportions of participants with Masked uncontrolled hypertension among different intervention groups(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of mean blood pressure during night-time(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of the ratios of night-time and daytime blood pressure(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of mean systolic blood pressure via home blood pressure monitoring(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of 24-hour mean blood pressure(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Proportion of participants with White-coat uncontrolled hypertension(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Differences of the proportions of participants with White-coat uncontrolled hypertension among different intervention groups(During the 2-3 years of follow-up of the main trial (ESPRIT))
- Compare the consistency of clinic-based blood pressure and out-office blood pressure(During the 2-3 years of follow-up of the main trial (ESPRIT))