Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude
- Conditions
- Altitude Hypoxia
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03536455
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACETAZOLAMIDE oral capsule ACETAZOLAMIDE oral capsule Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m PLACEBO oral capsule Placebo oral capsule Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
- Primary Outcome Measures
Name Time Method Change in maximal power output during exercise Day 1 at 760m and day 1 at 3'100m Difference in altitude-induced change in maximal power output between acetazolamide and placebo group.
- Secondary Outcome Measures
Name Time Method Change in muscle tissue oxygenation during exercise 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
Change in peak oxygen uptake during exercise Day 1 at 760m and day 1 at 3'100m Difference in altitude-induced change in peak oxygen uptake between acetazolamide and placebo group.
Change in arterial blood gasses at rest and peak exercise 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.
Change in cerebral tissue oxygenation during exercise 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
Trial Locations
- Locations (1)
National Center of Cardiology and Internal Medicine
🇰🇬Bishkek, Kyrgyzstan
National Center of Cardiology and Internal Medicine🇰🇬Bishkek, Kyrgyzstan