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

Overview

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.

Full Title of Study: “Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in maximal power output during exercise
    • 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.

Secondary Measures

  • Change in peak oxygen uptake during exercise
    • 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.
  • Change in cerebral tissue oxygenation during exercise
    • 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
  • Change in muscle tissue oxygenation during exercise
    • 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
  • Change in arterial blood gasses at rest and peak exercise
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Collaborator
    • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Konrad E Bloch, MD, Study Chair, University Hospital, Zürich
    • Talant M Sooronbaev, MD, Study Director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
    • Michael Furian, MSc, Principal Investigator, University Hospital, Zürich

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