A Phase 4 interventional study of ACETAZOLAMIDE oral capsule and Placebo oral capsule in Altitude Hypoxia, sponsored by University of Zurich. Status unknown at 1 site in Kyrgyzstan. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by University of Zurich · Phase 4, Interventional, and Prevention
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.
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.
189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.
This study's planned enrollment of 400 is above the median of 33 across 157 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
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
Time frame: Day 2 at 760m and 3100m
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
Time frame: Day 2 at 3100m
cardiac output
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3100m
cardiac output
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
Time frame: Day 2 at 3100m
right heart dimensions
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3100m
right heart dimensions
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3100m
right heart function
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time frame: Day 2 at 760m and 3100m
right heart function
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time frame: Day 2 at 3100m
stroke volume
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3100m
stroke volume
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
Time frame: Day 2 at 3100m
volumes
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3100m
volumes
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3100m
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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