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临床试验/NCT01508754
NCT01508754已完成4 期

Efficacy of Continuous Positive Airway Pressure (CPAP) on Blood Pressure Control of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome (OSAS).

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
125
试验地点
2
主要终点
clinic and ambulatory blood pressures

研究概览

简要总结

The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (OSAS).

详细描述

Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index [AHI] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome

排除标准

  • Older than 80 years
  • Pregnant women
  • Non-adherent to anti-hypertensive treatment
  • Severe cognitive deficits

结局指标

主要结局

clinic and ambulatory blood pressures

时间窗: 6 months

Clinic and ambulatory blood pressures (during 24-hour ambulatory blood pressure monitoring, which included both daytime and nighttime blood pressures, as well as the nocturnal dipping pattern).

次要结局

  • Arterial stiffness(6 months)
  • Aldosterone excess measurements(6 months)
  • Autonomic system measurements(6 months)
  • Cardiorespiratory fitness(6 months)
  • Microalbuminuria(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gil Fernando da Costa Mendes de Salles, PhD

Full Professor, Faculty of Medicine

Universidade Federal do Rio de Janeiro

研究点 (2)

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