Clinical trial NCT03561675: Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years
Official title: Acetazolamide for Prevention of Acute Mountain Sickness in Healthy Lowlanders Older Than 40 Years. Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Mountain Sickness
Keywords: healthy participants older than 40 years
altitude
prevention
acetazolamide
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2018-06-19
Enrollment: 349
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Detailed description: This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of acute mountain sickness (AMS) in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women, age 40-75 yrs, without any disease and need of medication.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.
* Kyrgyz ethnicity

Exclusion Criteria:

* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
* Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
* Allergy to acetazolamide and other sulfonamides.

Primary outcomes:
measure: Acute mountain sickness (AMS), incidence
timeFrame: Day 1 to 3 at 3'100m
Secondary outcomes:
measure: Acute mountain sickness (AMS), severity assessed by the Lake Louise score
timeFrame: Day 1 to 3 at 3'100m
measure: Acute mountain sickness (AMS) at 760 m with and without acetazolamide, severity
timeFrame: Day 3 at 760 m
measure: Altitude related adverse health effects (ARAHE), incidence
timeFrame: Day 1 to 3 at 3'100m
measure: Spirometric measurement of forced expiratory volume in one second
timeFrame: Day 2 at 760m and day 2 at 3'100m
measure: Arterial partical pressure of oxygen
timeFrame: Day 2 at 760m and day 2 at 3'100m
measure: Drug side effects
timeFrame: Day 1 to 3 at 3'100m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Zürich
name: Michael Furian, MSc
role: PRINCIPAL_INVESTIGATOR
References: