Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.

Altitude Hypoxia Clinical Trial

Official title:

Effect of Acetazolamide on Right Heart Function at Rest 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: NCT03540914
• Other study ID #: 2018-01-8/305E
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function at rest 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 preventive acetazolamide intake on right heart function at rest 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: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• 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.

Related Conditions & MeSH terms

• Altitude Hypoxia
• Altitude Sickness
• Hypoxia

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	Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group	Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo groups	Day 2 at 760m and 3100m
Secondary	Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group	Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group	Day 2 at 3100m
Secondary	cardiac output	Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3100m
Secondary	cardiac output	Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography	Day 2 at 3100m
Secondary	right heart dimensions	Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3100m
Secondary	right heart dimensions	Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 3100m
Secondary	right heart function	Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)	Day 2 at 760m and 3100m
Secondary	right heart function	Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)	Day 2 at 3100m
Secondary	stroke volume	Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3100m
Secondary	stroke volume	Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography	Day 2 at 3100m
Secondary	volumes	Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3100m
Secondary	volumes	Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 3100m