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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 visuo-motor learning performance 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 acetazolamide intake on visuo-motor learning performance 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 |
|---|---|---|
| Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group | Difference in altitude-induced change in directional error evaluated by the motor task manager during 760 m baseline measurements and measurements at 3100 m between acetazolamide and placebo group | Day 2 at 760m and 3'100m |
| Measure | Description | Time Frame |
|---|---|---|
| Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m | Altitude-induced change in visuomotor learning performance assessed at 760 m baseline and at 3100 m in the placebo and in the acetazolamide group | Day 1 and 2 at 760 m and at 3'100m |
| Change in arterial oxygen saturation |
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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 |
|---|---|---|---|
| 36662903 | Derived | Reiser AE, Furian M, Lichtblau M, Buergin A, Schneider SR, Appenzeller P, Mayer L, Muralt L, Mademilov M, Abdyraeva A, Aidaralieva S, Muratbekova A, Akylbekov A, Sheraliev U, Shabykeeva S, Sooronbaev TM, Ulrich S, Bloch KE. Effect of acetazolamide on visuomotor performance at high altitude in healthy people 40 years of age or older-RCT. PLoS One. 2023 Jan 20;18(1):e0280585. doi: 10.1371/journal.pone.0280585. 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 altitude-induced change of arterial oxygen saturation from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo group, measured by pulse oxymetry |
| Day 1 and 2 at 760 m and at 3'100m |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |