Clincosm LogoSign in Get a demo

Exp5300: Treatment of Chronic Mountain Sickness

Sponsor
Centre d'Expertise sur l'Altitude EXALT (Other)
Overall Status
Recruiting
CT.gov ID
NCT04251364
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
22.5
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
Actual Study Start Date :
Feb 15, 2020
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acetazolamide

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

Drug: Acetazolamide
Daily acetazolamide pill intake
Other Names:
  • Diamox

    		•
    Experimental: Atorvastatin

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

    Drug: Atorvastatin
    Daily atorvastatin pill intake
    Placebo Comparator: Placebo

    Oral placebo pill (daily) intake for 9 months

    Drug: Placebo oral tablet
    Daily placebo pill intake

    Outcome Measures

    Primary Outcome Measures

    1. Change in hematocrit [Change from before to after 9 months of treatment]

      Change in blood hematocrit value in percentage

    Secondary Outcome Measures

    1. 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

    2. Macrovascular reactivity [Change from before to after 9 months of treatment]

      Post-ischemia brachial artery dilation in %

    3. Microvascular reactivity [Change from before to after 9 months of treatment]

      Hyperthermic microvascular dilation in %

    4. Hemoglobin mass [Change from before to after 9 months of treatment]

      Total blood hemoglobin mass in mg

    5. Pulmonary arterial pressure [Change from before to after 9 months of treatment]

      Systolic and mean pulmonary arterial pressure in mmHg

    6. Blood pressure [Change from before to after 9 months of treatment]

      24-hour systolic and diastolic blood pressure

    7. Sleep recording [Change from before to after 9 months of treatment]

      Hypopnea-apnea index reported in number of events per hour

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley Échirolles France 38130

    Sponsors and Collaborators

    • Centre d'Expertise sur l'Altitude EXALT

    Investigators

    • Principal Investigator: Samuel Verges, PhD, EXAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre d'Expertise sur l'Altitude EXALT
    ClinicalTrials.gov Identifier:
    NCT04251364
    Other Study ID Numbers:
    • Expedition5300
    First Posted:
    Jan 31, 2020
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Altitude Sickness
    Hypoxia
    Acetazolamide
    Atorvastatin

    Study Results

    No Results Posted as of Aug 20, 2021