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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia
• Hypoxia, Altitude

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