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Completed

NCT Number: NCT04251364

Treatment of Chronic Mountain Sickness

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

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Key information

Conditions

Hypoxia, Altitude Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Échirolles, 38130, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

Daily acetazolamide pill intake

Other names: Diamox

atorvastatin

Drug

Daily atorvastatin pill intake

Placebo oral tablet

Drug

Daily placebo pill intake

Primary outcomes

  1. Change in hematocrit

    Time frame: Change from before to after 9 months of treatment

    Change in blood hematocrit value in percentage

Secondary outcomes

  1. Chronic mountain sickness score

    Time frame: 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

  2. Macrovascular reactivity

    Time frame: Change from before to after 9 months of treatment

    Post-ischemia brachial artery dilation in %

  3. Microvascular reactivity

    Time frame: Change from before to after 9 months of treatment

    Hyperthermic microvascular dilation in %

  4. Hemoglobin mass

    Time frame: Change from before to after 9 months of treatment

    Total blood hemoglobin mass in mg

  5. Pulmonary arterial pressure

    Time frame: Change from before to after 9 months of treatment

    Systolic and mean pulmonary arterial pressure in mmHg

  6. Blood pressure

    Time frame: Change from before to after 9 months of treatment

    24-hour systolic and diastolic blood pressure

  7. Sleep recording

    Time frame: Change from before to after 9 months of treatment

    Hypopnea-apnea index reported in number of events per hour

Sponsors and collaborators

Lead sponsor

Centre d'Expertise sur l'Altitude EXALT

Other

Registry information

Official study title

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

Acronym: Exp5300

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2020
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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