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NCT03537924 Clinical Trial

Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude

Altitude Hypoxia Clinical Trial

Official title:
Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03537924
Other study ID # 2018-01-8/305F
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2022

Study information
Verified date November 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Description:

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis on right heart function during exercise 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 200 participants will have completed the study and/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 information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ACETAZOLAMIDE oral capsule
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
• Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Locations
Country Name City State
Kyrgyzstan National Center of Cardiology and Internal Medicine Bishkek

Sponsors (2)
Lead Sponsor Collaborator
University of Zurich National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome
Type Measure Description Time frame Safety issue
Primary pulmonary artery pressure (PAP) during exercise Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 3100m
Secondary pulmonary artery pressure during exercise Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 760 m and 3100 m
Secondary cardiac Output (CO) during exercise Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 3100m
Secondary cardiac output during exercise Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 760 m and 3100 m
Secondary PAP/CO slope during exercise Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 3100m
Secondary PAP/CO slope during exercise Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer Day 2 at 760 m and 3100 m
Secondary Oxygen saturation Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter Day 2 at 3100m
Secondary Oxygen saturation Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter Day 2 at 760 m and 3100 m
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