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Treatment of Chronic Mountain Sickness (Exp5300)

Primary Purpose

Hypoxia, Altitude

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acetazolamide
Atorvastatin
Placebo oral tablet
Sponsored by
Centre d'Expertise sur l'Altitude EXALT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia, Altitude

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue KimberleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Atorvastatin

Placebo

Arm Description

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

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

Oral placebo pill (daily) intake for 9 months

Outcomes

Primary Outcome Measures

Change in hematocrit
Change in blood hematocrit value in percentage

Secondary Outcome Measures

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
Macrovascular reactivity
Post-ischemia brachial artery dilation in %
Microvascular reactivity
Hyperthermic microvascular dilation in %
Hemoglobin mass
Total blood hemoglobin mass in mg
Pulmonary arterial pressure
Systolic and mean pulmonary arterial pressure in mmHg
Blood pressure
24-hour systolic and diastolic blood pressure
Sleep recording
Hypopnea-apnea index reported in number of events per hour

Full Information

First Posted
January 29, 2020
Last Updated
August 19, 2021
Sponsor
Centre d'Expertise sur l'Altitude EXALT
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1. Study Identification

Unique Protocol Identification Number
NCT04251364
Brief Title
Treatment of Chronic Mountain Sickness
Acronym
Exp5300
Official Title
Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Expertise sur l'Altitude EXALT

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
Oral acetazolamide (250 mg/day) intake for 9 months
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Oral atorvastatin (40 mg/day) intake for 9 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo pill (daily) intake for 9 months
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Daily acetazolamide pill intake
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Daily atorvastatin pill intake
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Daily placebo pill intake
Primary Outcome Measure Information:
Title
Change in hematocrit
Description
Change in blood hematocrit value in percentage
Time Frame
Change from before to after 9 months of treatment
Secondary Outcome Measure Information:
Title
Chronic mountain sickness score
Description
Chronic mountain sickness score (between 0 and 24, the higher the score the more severe the sickness) according to the available international scoring system
Time Frame
Change from before to after 9 months of treatment
Title
Macrovascular reactivity
Description
Post-ischemia brachial artery dilation in %
Time Frame
Change from before to after 9 months of treatment
Title
Microvascular reactivity
Description
Hyperthermic microvascular dilation in %
Time Frame
Change from before to after 9 months of treatment
Title
Hemoglobin mass
Description
Total blood hemoglobin mass in mg
Time Frame
Change from before to after 9 months of treatment
Title
Pulmonary arterial pressure
Description
Systolic and mean pulmonary arterial pressure in mmHg
Time Frame
Change from before to after 9 months of treatment
Title
Blood pressure
Description
24-hour systolic and diastolic blood pressure
Time Frame
Change from before to after 9 months of treatment
Title
Sleep recording
Description
Hypopnea-apnea index reported in number of events per hour
Time Frame
Change from before to after 9 months of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Verges, PhD
Phone
0476766860
Ext
33
Email
sverges@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Verges, PhD
Organizational Affiliation
EXAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley
City
Échirolles
ZIP/Postal Code
38130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Verges, PhD
Phone
476766860
Ext
33
Email
sverges@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Chronic Mountain Sickness

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