Treatment of Chronic Mountain Sickness (Exp5300)

Centre d'Expertise sur l'Altitude EXALT

Status: Unknown

Conditions: Hypoxia, Altitude

Treatments: Drug: Placebo oral tablet; Drug: Atorvastatin; Drug: Acetazolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04251364

Expedition5300

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Acetazolamide

Experimental group

Description:

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

Treatment:

Drug: Acetazolamide

Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Oral placebo pill (daily) intake for 9 months

Treatment:

Drug: Placebo oral tablet