Treatment of Chronic Mountain Sickness

NCT ID: NCT04251364

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypoxia, Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acetazolamide

Oral acetazolamide (250 mg/day) intake for 9 months

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

Daily acetazolamide pill intake

Atorvastatin

Oral atorvastatin (40 mg/day) intake for 9 months

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Daily atorvastatin pill intake

Placebo

Oral placebo pill (daily) intake for 9 months

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Daily placebo pill intake

Interventions

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Acetazolamide

Daily acetazolamide pill intake

Intervention Type DRUG

Atorvastatin

Daily atorvastatin pill intake

Intervention Type DRUG

Placebo oral tablet

Daily placebo pill intake

Intervention Type DRUG

Other Intervention Names

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Diamox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre d'Expertise sur l'Altitude EXALT

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Verges, PhD

Role: PRINCIPAL_INVESTIGATOR

EXAL

Locations

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Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley

Échirolles, , France

Site Status

Countries

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France

Other Identifiers

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Expedition5300

Identifier Type: -

Identifier Source: org_study_id

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