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Treatment of Chronic Mountain Sickness (Exp5300)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251364
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Centre d'Expertise sur l'Altitude EXALT

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
Hypoxia, Altitude Drug: Acetazolamide Drug: Atorvastatin Drug: Placebo oral tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 15, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetazolamide
Oral acetazolamide (250 mg/day) intake for 9 months
Drug: Acetazolamide
Daily acetazolamide pill intake
Other Name: 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




Primary Outcome Measures :
  1. Change in hematocrit [ Time Frame: Change from before to after 9 months of treatment ]
    Change in blood hematocrit value in percentage


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251364


Contacts
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Contact: Samuel Verges, PhD 0476766860 ext 33 sverges@chu-grenoble.fr

Locations
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France
Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley Recruiting
Échirolles, France, 38130
Contact: Samuel Verges, PhD    476766860 ext 33    sverges@chu-grenoble.fr   
Sponsors and Collaborators
Centre d'Expertise sur l'Altitude EXALT
Investigators
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Principal Investigator: Samuel Verges, PhD EXAL
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Responsible Party: Centre d'Expertise sur l'Altitude EXALT
ClinicalTrials.gov Identifier: NCT04251364    
Other Study ID Numbers: Expedition5300
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Altitude Sickness
Hypoxia
Signs and Symptoms, Respiratory
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs