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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
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Randomized, placebo controlled trial evaluating the effect of acetazolamide on postural control 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 effect of preventive acetazolamide intake on the postural control 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 80 participants will have completed the study 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Active Comparator | 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 |
|
| PLACEBO oral capsule | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Drug | Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in anterio-posterior sway velocity (AP) | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of AP sway velocity between acetazolamide and placebo group, measured by a balance platform | Day 2 at 760m and 3'100m |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial oxygen saturation | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oximetry | Day 2 at 760m and 3'100m |
| Acute mountain sickness, severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University Hospital, Zürich | Study Chair |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Michael Furian, MSc | University Hospital, Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Bishkek | 720040 | Kyrgyzstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38250659 | Derived | Mutschler T, Furian M, Lichtblau M, Buergin A, Schneider SR, Appenzeller P, Mayer L, Muralt L, Mademilov M, Abdyraeva A, Aidaralieva S, Muratbekova A, Akylbekov A, Shabykeeva S, Sooronbaev TM, Ulrich S, Bloch KE. Effect of altitude and acetazolamide on postural control in healthy lowlanders 40 years of age or older. Randomized, placebo-controlled trial. Front Physiol. 2024 Jan 4;14:1274111. doi: 10.3389/fphys.2023.1274111. eCollection 2023. |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo oral capsule | Drug | Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m |
|
Difference in acute mountain sickness severity on day 2 at 3'100 meters a.s.l. between acetazolamide and placebo group. |
| Day 2 at 3'100m |
| Change in cerebral tissue oxygenation | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of cerebral tissue oxygenation between acetazolamide and placebo group, measured by near-infrared spectroscopy. | Day 2 at 760m and 3'100m |
| Change in muscle tissue oxygenation | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3'100 meters a.s.l.) of muscle tissue oxygenation between acetazolamide and placebo group, measured by near-infrared spectroscopy. | Day 2 at 760m and 3'100m |
| AP sway velocity with and without study medication | Difference in AP sway velocity between acetazolamide and placebo group at 760 m. | Day 3 at 760m |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |