This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Daily acetazolamide pill intake
Daily atorvastatin pill intake
Daily placebo pill intake
Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley
Échirolles, France
Change in hematocrit
Change in blood hematocrit value in percentage
Time frame: Change from before to after 9 months of treatment
Chronic mountain sickness score
Chronic mountain sickness score (between 0 and 24, the higher the score the more severe the sickness) according to the available international scoring system
Time frame: Change from before to after 9 months of treatment
Macrovascular reactivity
Post-ischemia brachial artery dilation in %
Time frame: Change from before to after 9 months of treatment
Microvascular reactivity
Hyperthermic microvascular dilation in %
Time frame: Change from before to after 9 months of treatment
Hemoglobin mass
Total blood hemoglobin mass in mg
Time frame: Change from before to after 9 months of treatment
Pulmonary arterial pressure
Systolic and mean pulmonary arterial pressure in mmHg
Time frame: Change from before to after 9 months of treatment
Blood pressure
24-hour systolic and diastolic blood pressure
Time frame: Change from before to after 9 months of treatment
Sleep recording
Hypopnea-apnea index reported in number of events per hour
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Time frame: Change from before to after 9 months of treatment