Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in hematocrit
研究概览
简要总结
This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.
详细描述
About 100 million individuals reside at high altitude (>2500m) worldwide, with the largest populations of highlanders being found in South America (Andean), central Asia (Tibetan and Sherpa) and East Africa (Ethiopian). Despite unique adaptations to hypoxia in these populations, chronic mountain sickness (CMS) is a clinical syndrome which is observed in 5-33% of individuals residing permanently at high altitude.Several pharmacological approaches have been proposed in the treatment of EE and CMS. However, few studies show sufficient clinical evidence for safety and efficacy in CMS treatment and most highlanders with CMS remain untreated. The present project aims to better characterize chronic hypoxic responses in highlanders and to evaluate the interest of acetazolamide and statins as potential treatments for chronic mountain sickness.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55 yrs
- •Body mass index <30kg/m²
- •Born at >3500 m, living for >3 years at the local high altitude
- •No diagnosis of cardiorespiratory, metabolic or neurological diseases
- •No drug intake
- •No smoker
- •Chronic mountain sickness score ≥6
排除标准
- •Diagnosis of cardiorespiratory, metabolic and neurological diseases
- •Systolic > 130 mmHg and/or diastolic > 85 mmHg blood pressure
- •Drug intake
- •Chronic mountain sickness score <6
研究组 & 干预措施
Acetazolamide
Oral acetazolamide (250 mg/day) intake for 9 months
干预措施: Acetazolamide (Drug)
Atorvastatin
Oral atorvastatin (40 mg/day) intake for 9 months
干预措施: Atorvastatin (Drug)
Placebo
Oral placebo pill (daily) intake for 9 months
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in hematocrit
时间窗: Change from before to after 9 months of treatment
Change in blood hematocrit value in percentage
次要结局
- Hemoglobin mass(Change from before to after 9 months of treatment)
- Chronic mountain sickness score(Change from before to after 9 months of treatment)
- Macrovascular reactivity(Change from before to after 9 months of treatment)
- Microvascular reactivity(Change from before to after 9 months of treatment)
- Blood pressure(Change from before to after 9 months of treatment)
- Sleep recording(Change from before to after 9 months of treatment)
- Pulmonary arterial pressure(Change from before to after 9 months of treatment)