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

Learn more about:
Related Clinical Trial
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude. Effect of Acetazolamide on Lung Water Content by Ultrasound in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance Iron Status and Cardiopulmonary Physiology Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude. Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During Sleep in High Altitude The Psychophysiological Effect of Simulated and Terrestrial Altitude Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude AZ, MZ, and the Pulmonary System Response to Hypoxia Study of the Effects of Iron Levels on the Lungs at High Altitude Effects of Aircraft Cabin Altitude on Passenger Comfort and Discomfort Three New Ideas to Protect Special Forces From the Stress of High Altitude Breathing Training to Improve Human Performance at High Altitude Oxidative Stress in Hypobaric Hypoxia Safety Evaluation of Aminophylline and Methazolamide Decompression Tables for Diving at Altitude Chronic Mountain Sickness, Systemic Vascular Function Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness Inhaled Budesonide for Altitude Illness Prevention Sickness Evaluation at Altitude With Acetazolamide at Relative Doses Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS) Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE) Drug Combination on Exercise Performance at High Altitude Acclimatization Mechanisms During Ascent to 7500m Prevention of Acute Mountain Sickness by Intermittent Hypoxia Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID) Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent Training in Hypoxia to Prevent Acute Mountain Sickness Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness Inhaled Budesonide and Acute Mountain Sickness Altitude Sickness Prevention and Efficacy of Comparative Treatments Alternative Treatments in Acute Mountain Sickness Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)

Brief Title

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

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in maximal power output during exercise

Secondary Outcome

 Change in peak oxygen uptake during exercise

Condition

Altitude Hypoxia

Intervention

ACETAZOLAMIDE oral capsule

Study Arms / Comparison Groups

 ACETAZOLAMIDE oral capsule
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

June 1, 2018

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

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.
      

Gender

All

Ages

40 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Konrad E Bloch, MD, , 

Location Countries

Kyrgyzstan

Location Countries

Kyrgyzstan

Administrative Informations


NCT ID

NCT03536455

Organization ID

2018-01-8/305B


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

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

Study Sponsor

Konrad E Bloch, MD, Study Chair, University Hospital, Zürich


Verification Date

January 2020