Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT03536455
Collaborator
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov (Other)
92
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2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ACETAZOLAMIDE oral capsule
  • Drug: Placebo oral capsule
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Actual Study Start Date :
May 15, 2018
Actual Primary Completion Date :
Aug 2, 2018
Actual Study Completion Date :
Aug 2, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Drug: ACETAZOLAMIDE oral capsule
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

Placebo Comparator: 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

Drug: Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Center of Cardiology and Internal Medicine Bishkek Kyrgyzstan 720040

Sponsors and Collaborators

  • University of Zurich
  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Investigators

  • Study Chair: Konrad E Bloch, MD, University Hospital, Zürich
  • Study Director: Talant M Sooronbaev, MD, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
  • Principal Investigator: Michael Furian, MSc, University Hospital, Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT03536455
Other Study ID Numbers:
  • 2018-01-8/305B
First Posted:
May 24, 2018
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Zurich
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021