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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Experimental | Oral acetazolamide (250 mg/day) intake for 9 months |
|
| Atorvastatin | Experimental | Oral atorvastatin (40 mg/day) intake for 9 months |
|
| Placebo | Placebo Comparator | Oral placebo pill (daily) intake for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Daily acetazolamide pill intake |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hematocrit | Change in blood hematocrit value in percentage | Change from before to after 9 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from before to after 9 months of treatment |
| Macrovascular reactivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Verges, PhD | EXAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley | Échirolles | 38130 | France |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Atorvastatin | Drug | Daily atorvastatin pill intake |
|
| Placebo oral tablet | Drug | Daily placebo pill intake |
|
Post-ischemia brachial artery dilation in % |
| Change from before to after 9 months of treatment |
| Microvascular reactivity | Hyperthermic microvascular dilation in % | Change from before to after 9 months of treatment |
| Hemoglobin mass | Total blood hemoglobin mass in mg | Change from before to after 9 months of treatment |
| Pulmonary arterial pressure | Systolic and mean pulmonary arterial pressure in mmHg | Change from before to after 9 months of treatment |
| Blood pressure | 24-hour systolic and diastolic blood pressure | Change from before to after 9 months of treatment |
| Sleep recording | Hypopnea-apnea index reported in number of events per hour | Change from before to after 9 months of treatment |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |