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临床试验/NCT00843583
NCT00843583已完成不适用

A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
ambulatory blood pressure

研究概览

简要总结

This study aims to investigate the prevalence of obstructive sleep apnea (OSA) in subjects with resistant hypertension and to evaluate the relationship between parameters of OSA severity and blood pressure control

详细描述

Obstructive sleep apnea (OSA) is characterized by intermittent upper airway collapse during sleep, which results in hypoxia, arousals and surge in sympathetic activity. There is robust evidence to support a contributing role of OSA in hypertension (HT). The Sleep Heart Health Study (1), which recruited more than 6000 subjects having polysomnogram at home, found an independent association between OSA and HT. The adjusted odds ratio was 1.37 for subjects with and apnea-hypopnea index >= 30/hour compared to those without apnea. The Wisconsin Sleep Cohort Study , which provided prospective longitudinal follow-up for OSA subjects over 4 years, have shown dose dependency of the severity of OSA and the risk of development of HT. Current available data suggests that in hypertensive patients with severe OSA, there is a BP drop of about 10mmHg with CPAP treatment (2-5). The blood pressure (BP) lowering effect of CPAP treatment in the group with mild asymptomatic OSA is less consolidated.

The relationship between BP and risk of cardiovascular events is continuous, consistent, and independent of other risk factors. A strict blood pressure control is imperative in subjects with diabetes mellitus or renal impairment. Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. (6) Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT (6), paucity of works has demonstrated the scale of problems of untreated OSA in subjects with resistant HT. (7-9) There is so far one study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though no randomization was implemented and the sample size was limited (n=11). (10) We aim at conducting a cross-sectional study to explore the situation which would guide further clinical trial.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≧ 3 anti-HT drugs
  • age 18-65
  • mentally fit for signing an informed written consent

排除标准

  • moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
  • endocrine/renal/cardiac causes of secondary HT
  • congestive heart failure and clinically fluid overloaded
  • On drugs that elevate BP e.g. alcohol, NSAID, steroid

结局指标

主要结局

ambulatory blood pressure

时间窗: 24 hour

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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