Treatment of Chronic Mountain Sickness (Exp5300)

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia, Altitude
• Intervention / Treatment: Drug: Acetazolamide; Drug: Atorvastatin; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel Verges, PhD; Phone Number: 33 0476766860; Email: sverges@chu-grenoble.fr

Study Locations

• France
  • Échirolles, France, 38130
    • Recruiting
    • Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley
    • Contact: Samuel Verges, PhD; Phone Number: 33 476766860; Email: sverges@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hematocrit	Change in blood hematocrit value in percentage	Change from before to after 9 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from before to after 9 months of treatment
Macrovascular reactivity	Post-ischemia brachial artery dilation in %	Change from before to after 9 months of treatment
Microvascular reactivity	Hyperthermic microvascular dilation in %	Change from before to after 9 months of treatment
Hemoglobin mass	Total blood hemoglobin mass in mg	Change from before to after 9 months of treatment
Pulmonary arterial pressure	Systolic and mean pulmonary arterial pressure in mmHg	Change from before to after 9 months of treatment
Blood pressure	24-hour systolic and diastolic blood pressure	Change from before to after 9 months of treatment
Sleep recording	Hypopnea-apnea index reported in number of events per hour	Change from before to after 9 months of treatment

Collaborators and Investigators

• Sponsor: Centre d'Expertise sur l'Altitude EXALT
• Investigators: Principal Investigator: Samuel Verges, PhD, EXAL

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2020
• Primary Completion (ANTICIPATED): October 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Diuretics; Anticonvulsants; Atorvastatin; Acetazolamide
• Other Study ID Numbers: Expedition5300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No