National Center of Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03536455
Randomized, placebo controlled trial evaluating the effect of acetazolamide on maximal exercise performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.
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Notify Me40 year–75 year
All sexes
Interventional
Phase 4
Bishkek, 720040, Kyrgyzstan
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on the maximal exercise performance 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
Time frame: Day 1 at 760m and day 1 at 3'100m
Difference in altitude-induced change in maximal power output between acetazolamide and placebo group.
Time frame: Day 1 at 760m and day 1 at 3'100m
Difference in altitude-induced change in peak oxygen uptake between acetazolamide and placebo group.
Time frame: Day 1 at 760m and day 1 at 3'100m
Difference in altitude-induced change in cerebral tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry
Time frame: Day 1 at 760m and day 1 at 3'100m
Difference in altitude-induced change in muscular tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry
Time frame: Day 1 at 760m and day 1 at 3'100m
Difference in altitude-induced change in arterial blood gases between acetazolamide and placebo measured before and at peak exercise.
University of Zurich
Other
Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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