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Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

2012年7月8日 更新者:George S. Stergiou、University of Athens

Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

81

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Athens、希腊、11527
        • Sotiria General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:ma

  • 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

Exclusion Criteria:

  • Sustained arrythmia
  • Pregnancy
  • Symptomatic cardiovascular disease
  • Any other serious disease (renal failure, heart failure, malignancy)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:All patients
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
其他名称:
  • Microlife WatchBP Home Nocturnal
  • Microlife 手表BP O3

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Awake Systolic Home Blood Pressure Measurement
大体时间:2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
2 weeks
Awake Diastolic Home Blood Pressure Measurement
大体时间:2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
2 weeks
Asleep Systolic Home Blood Pressure Measurement
大体时间:2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
2 weeks
Asleep Diastolic Home Blood Pressure Measurement
大体时间:2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
2 weeks
Awake Systolic Ambulatory Blood Pressure Measurement
大体时间: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.
2 weeks
Awake Diastolic Ambulatory Blood Pressure Measurement
大体时间: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.
2 weeks
Asleep Systolic Ambulatory Blood Pressure Measurement
大体时间: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.
2weeks
Asleep Diastolic Ambulatory Blood Pressure Measurement
大体时间: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.
2weeks

次要结果测量

结果测量
措施说明
大体时间
Dippers Defined by ABPM and HBPM-Nocturnal
大体时间:2 weeks
As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.
2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年11月1日

初级完成 (实际的)

2011年12月1日

研究完成 (实际的)

2011年12月1日

研究注册日期

首次提交

2011年10月25日

首先提交符合 QC 标准的

2011年10月26日

首次发布 (估计)

2011年10月27日

研究记录更新

最后更新发布 (估计)

2012年7月10日

上次提交的符合 QC 标准的更新

2012年7月8日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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