National Center for Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03173508
This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at acute altitude exposure in patients with COPD.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Bishkek, 720040, Kyrgyzstan
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at rest in lowlanders with chronic obstructive pulmonary disease 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 (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
Right ventricular function will be assessed by transthoracic echocardiography.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of pulmonary artery pressure (PAP) between acetazolamide and placebo group, measured by transthoracic echocardiography (tricuspid pressure gradient and pulmonary valve acceleration time)
Time frame: Day 2 at 3200m
Difference at altitude of pulmonary artery pressure (PAP) between acetazolamide and placebo group, measured by transthoracic echocardiography (tricuspid pressure gradient and pulmonary valve acceleration time)
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3200m
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3200m
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time frame: Day 2 at 3200m
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3200m
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time frame: Day 2 at 3200m
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
University of Zurich
Other
Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Chronic Obstructive Pulmonary Disease at Altitude. A Randomized, Placebo-controlled, Double-blind Parallel Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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