Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Awake Systolic Home Blood Pressure Measurement
研究概览
简要总结
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:
Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.
详细描述
Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.
Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.
Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for high blood pressure
- •Age over 30 years
- •Untreated for hypertension or under stable treatment for 4 weeks or more
- •Patients physically and mentally capable for self-measurement of blood pressure at home
- •Written informed consent to participate in the study
排除标准
- •Sustained arrythmia
- •Pregnancy
- •Symptomatic cardiovascular disease
- •Any other serious disease (renal failure, heart failure, malignancy)
结局指标
主要结局
Awake Systolic Home Blood Pressure Measurement
时间窗: 2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Awake Diastolic Home Blood Pressure Measurement
时间窗: 2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Asleep Systolic Home Blood Pressure Measurement
时间窗: 2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Asleep Diastolic Home Blood Pressure Measurement
时间窗: 2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Awake Systolic Ambulatory Blood Pressure Measurement
时间窗: 2 weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Awake Diastolic Ambulatory Blood Pressure Measurement
时间窗: 2 weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Asleep Systolic Ambulatory Blood Pressure Measurement
时间窗: 2weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Asleep Diastolic Ambulatory Blood Pressure Measurement
时间窗: 2weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
次要结局
- Dippers Defined by ABPM and HBPM-Nocturnal(2 weeks)
研究者
George S. Stergiou
Associate Professor of Medicine and Hypertension
University of Athens