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NCT04251364 Clinical Trial

Treatment of Chronic Mountain Sickness

Hypoxia, Altitude Clinical Trial

— Exp5300  

Official title:
Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04251364
Other study ID # Expedition5300
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2020
Est. completion date December 30, 2021

Study information
Verified date February 2021
Source Centre d'Expertise sur l'Altitude EXALT
Contact Samuel Verges, PhD
Phone 0476766860
Email sverges@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Acetazolamide
Daily acetazolamide pill intake
• Atorvastatin
Daily atorvastatin pill intake
• Placebo oral tablet
Daily placebo pill intake

Locations
Country Name City State
France Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley Échirolles

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Expertise sur l'Altitude EXALT

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in hematocrit Change in blood hematocrit value in percentage Change from before to after 9 months of treatment
Secondary 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
Secondary Macrovascular reactivity Post-ischemia brachial artery dilation in % Change from before to after 9 months of treatment
Secondary Microvascular reactivity Hyperthermic microvascular dilation in % Change from before to after 9 months of treatment
Secondary Hemoglobin mass Total blood hemoglobin mass in mg Change from before to after 9 months of treatment
Secondary Pulmonary arterial pressure Systolic and mean pulmonary arterial pressure in mmHg Change from before to after 9 months of treatment
Secondary Blood pressure 24-hour systolic and diastolic blood pressure Change from before to after 9 months of treatment
Secondary Sleep recording Hypopnea-apnea index reported in number of events per hour Change from before to after 9 months of treatment
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