National Center for Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03167034
This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise 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 during exercise 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 during graded cycling on an ergometer 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 3200m
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
Time frame: Day 2 at 760 m and 3200 m
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
Time frame: Day 2 at 3200m
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
Time frame: Day 2 at 760 m and 3200 m
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
Time frame: Day 2 at 3200m
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
Time frame: Day 2 at 760 m and 3200 m
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
Time frame: Day 2 and 3200 m
Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter
Time frame: Day 2 at 760 m and 3200 m
Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter
University of Zurich
Other
Effect of Acetazolamide on Right Ventricular Function During Exercise 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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