NCT00777985已完成2 期
Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2007年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- 24 hour mean diastolic blood pressure
研究概览
简要总结
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.
The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Documented obstructive sleep apnea
- •with untreated mild systemic hypertension
排除标准
- •pregnancy or lactation
- •daytime alveolar hypoventilation
- •severe arterial hypertension (systolic pressure > 180 mmHg; diastolic pressure > 110 mmHg)
- •treatment with anti-hypertensive drugs
- •cardiovascular disorder other than mild hypertension
- •severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
- •contra-indication to nCPAP treatment
- •known allergy to bosentan
- •active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
- •active treatment with a drug acting on systemic arterial blood pressure or endothelial function
- •liver or kidney dysfunction
研究组 & 干预措施
1
Experimental
干预措施: bosentan (Drug)
2
Active Comparator
干预措施: nasal continuous positive airway pressure (CPAP) (Device)
结局指标
主要结局
24 hour mean diastolic blood pressure
时间窗: before and after each treatment completion (4 weeks)
次要结局
- Peripheral Arterial Tonometry measure(before and after each treatment completion (4 weeks))
- mean 24 hour systemic systolic blood pressure(before and after each treatment completion (4 weeks))
- mean 24 hour nocturnal blood pressure(before and after each treatment completion (4 weeks))
- carotid Intima Media Thickness(before and after each treatment completion (4 weeks))
- Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma(before and after each treatment completion (4 weeks))
- Circulating Big ET1 and ET1 levels(before and after each treatment completion (4 weeks))
研究者
研究点 (1)
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