Hypoxia, AltitudeExp5300NCT04251364
Treatment of Chronic Mountain Sickness
A study testing Acetazolamide and Atorvastatin in people with Hypoxia, Altitude, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in France.
Trial summary
This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- Acetazolamide and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley
Échirolles, 38130
About this study
Official title: Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.
Read the 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.
- Conditions
- Hypoxia, Altitude
- Being tested
- Acetazolamide, Atorvastatin, Placebo oral tablet
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Daily acetazolamide pill intake
AtorvastatinDrug
Daily atorvastatin pill intake
Placebo oral tabletDrug
Daily placebo pill intake
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Oral acetazolamide (250 mg/day) intake for 9 months Receives: Drug: Acetazolamide |
| Atorvastatin | Experimental | Oral atorvastatin (40 mg/day) intake for 9 months Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Oral placebo pill (daily) intake for 9 months Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hematocrit
Change in blood hematocrit value in percentage
Measured: Change from before to after 9 months of treatment
Secondary outcomes (7)
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
Measured: Change from before to after 9 months of treatment
Macrovascular reactivity
Post-ischemia brachial artery dilation in %
Measured: Change from before to after 9 months of treatment
Microvascular reactivity
Hyperthermic microvascular dilation in %
Measured: Change from before to after 9 months of treatment
Hemoglobin mass
Total blood hemoglobin mass in mg
Measured: Change from before to after 9 months of treatment
Pulmonary arterial pressure
Systolic and mean pulmonary arterial pressure in mmHg
Measured: Change from before to after 9 months of treatment
Blood pressure
24-hour systolic and diastolic blood pressure
Measured: Change from before to after 9 months of treatment
Sleep recording
Hypopnea-apnea index reported in number of events per hour
Measured: Change from before to after 9 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Feb 2020
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Verges, PhD, Principal investigator, EXAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251364
- Sponsor's protocol ID
- Expedition5300
- Acronym
- Exp5300
- Status last verified
- Jul 2025
- First submitted
- 29 Jan 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04251364
- Acronym / sponsor ID
- Exp5300 / Expedition5300
- Conditions
- Hypoxia, Altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALTUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideOral acetazolamide (250 mg/day) intake for 9 months |
| Atorvastatin | Experimental | Drug: AtorvastatinOral atorvastatin (40 mg/day) intake for 9 months |
| Placebo | Placebo comparator | Drug: Placebo oral tabletOral placebo pill (daily) intake for 9 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: DiamoxDaily acetazolamide pill intake | Drug | Acetazolamide |
| AtorvastatinDaily atorvastatin pill intake | Drug | Atorvastatin |
| Placebo oral tabletDaily placebo pill intake | Drug | Placebo |
Primary outcome
Change in hematocrit
Time frame: Change from before to after 9 months of treatment
Change in blood hematocrit value in percentage
7 secondary outcomes
Chronic mountain sickness score
Time frame: Change from before to after 9 months of treatment
Macrovascular reactivity
Time frame: Change from before to after 9 months of treatment
Microvascular reactivity
Time frame: Change from before to after 9 months of treatment
Hemoglobin mass
Time frame: Change from before to after 9 months of treatment
Pulmonary arterial pressure
Time frame: Change from before to after 9 months of treatment
Blood pressure
Time frame: Change from before to after 9 months of treatment
Sleep recording
Time frame: Change from before to after 9 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Verges, PhD principal investigator
EXAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetazolamide and Atorvastatin in people with Hypoxia, Altitude, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hematocrit (time frame: Change from before to after 9 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.