Treatment of Chronic Mountain Sickness

Not Applicable

• Conditions: Hypoxia, Altitude
• Interventions: Drug: Placebo oral tablet; Drug: Atorvastatin; Drug: Acetazolamide

• Registration Number: NCT04251364
• Lead Sponsor: Centre d'Expertise sur l'Altitude EXALT

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.

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-02-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-20
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	Oral placebo pill (daily) intake for 9 months
Atorvastatin	Atorvastatin	Oral atorvastatin (40 mg/day) intake for 9 months
Acetazolamide	Acetazolamide	Oral acetazolamide (250 mg/day) intake for 9 months

Primary Outcome Measures

Name	Time	Method
Change in hematocrit	Change from before to after 9 months of treatment	Change in blood hematocrit value in percentage

Secondary Outcome Measures

Name	Time	Method
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
Macrovascular reactivity	Change from before to after 9 months of treatment	Post-ischemia brachial artery dilation in %
Hemoglobin mass	Change from before to after 9 months of treatment	Total blood hemoglobin mass in mg
Microvascular reactivity	Change from before to after 9 months of treatment	Hyperthermic microvascular dilation in %
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

Trial Locations

Locations (1)

Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley; 🇫🇷 Échirolles, France