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临床试验/NCT01533584
NCT01533584Unknown不适用

Evaluation of Nocturnal Hypertension With 24-hour Ambulatory or Home Blood Pressure Measurement: Correlation With Target-Organ Damage

University of Athens2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2

研究概览

简要总结

The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison of the potential of the two methods to define non-dippers.

详细描述

It is well known that blood pressure (BP) exhibits diurnal variation. Nocturnal fall of BP normally exceeds 10%. Subjects with such fall of BP during sleep are classified as "dippers" and those with a nocturnal fall of BP less than 10% are classified as "non-dippers". Non-dippers are exposed to a greater cardiovascular risk. To date dipping status is defined with 24-hour ambulatory BP monitoring (ABPM). Many studies have shown that Home BP monitoring (HBPM) can be an alternative to daytime ambulatory BP monitoring and it exhibits similar correlation to markers of hypertension target-organ-damage (TOD). Nocturnal hypertension shows closer correlation with TOD, than daytime hypertension. In this study patients will be provided with a new-technology, reliable oscillometric device for HBPM, equipped with a modified algorithm, which allows scheduled automated BP measurements during sleep (Microlife WatchBP Home Nocturnal). Duplicate morning and evening BP measurements with one-minute interval will be performed by the patient sitting during seven working days. Afterwards a 24-hour ABPM will be performed, using Microlife WatchBP O3 oscillometric device, with a 20-minute interval between measurements. This order may be reversed according to the wish of the patient and devices' availability. Participants will visit site 3 times. Office blood pressure will be measured during two visits. Triplicate measurements with Microlife WatchBP Home Nocturnal will be performed at the sitting position.

TOD will be assessed with:

  • cardiac triplex (LVMI)
  • carotid triplex (ΙΜΤ)
  • pulse wave velocity.
  • Albumin/creatinine ratio measured in morning urine sample.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mean 24-hour Systolic BP (SBP) >130 mmHg and/or Mean 24-hour Diastolic BP (DBP) >80 mmHg.
  • Patients physically and mentally capable of self-measuring BP at home.
  • Written informed consent.

排除标准

  • Sustained arrhythmia.
  • Pregnancy.
  • Symptomatic cardiovascular disease.
  • Any other serious illness (cardiac, renal, or malignancy).

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

George S. Stergiou

Associate Professor of Medicine and Hypertension

University of Athens

研究点 (2)

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