Hypoxia, Altitude
Conditions
Brief summary
This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.
Detailed description
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.
Interventions
DRUGAcetazolamide
Daily acetazolamide pill intake
DRUGAtorvastatin
Daily atorvastatin pill intake
DRUGPlacebo oral tablet
Daily placebo pill intake
Sponsors
Centre d'Expertise sur l'Altitude EXALT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male * 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
Exclusion criteria
* Diagnosis of cardiorespiratory, metabolic and neurological diseases * Systolic \> 130 mmHg and/or diastolic \> 85 mmHg blood pressure * Drug intake * Smoker * Chronic mountain sickness score \<6
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hematocrit | Change from before to after 9 months of treatment | Change in blood hematocrit value in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macrovascular reactivity | Change from before to after 9 months of treatment | Post-ischemia brachial artery dilation in % |
| Microvascular reactivity | Change from before to after 9 months of treatment | Hyperthermic microvascular dilation in % |
| Hemoglobin mass | Change from before to after 9 months of treatment | Total blood hemoglobin mass in mg |
| Chronic mountain sickness score | Change from before to after 9 months of treatment | Chronic mountain sickness score (between 0 and 24, the higher the score the more severe the sickness) according to the available international scoring system |
| Blood pressure | Change from before to after 9 months of treatment | 24-hour systolic and diastolic blood pressure |
| Sleep recording | Change from before to after 9 months of treatment | Hypopnea-apnea index reported in number of events per hour |
| Pulmonary arterial pressure | Change from before to after 9 months of treatment | Systolic and mean pulmonary arterial pressure in mmHg |
Countries
France
Outcome results
None listed