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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 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.
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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 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 | Day 2 at 760m and 3100m |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 2 at 3100m |
| cardiac output |
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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 |
| Silvia Ulrich, MD | 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 |
|---|---|---|---|
| 40878988 | Derived | Mayer L, Lichtblau M, Furian M, Buergin A, Saxer S, Mademilov M, Bader PR, Schneider SR, Sooronbaev T, Bloch KE, Ulrich S. Effect of Acetazolamide on Pulmonary Hemodynamics and Right Heart Function in Healthy Adults Going to Altitude: A Randomized Controlled Trial. J Am Heart Assoc. 2025 Sep 2;14(17):e041941. doi: 10.1161/JAHA.125.041941. Epub 2025 Aug 29. |
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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 cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography |
| Day 2 at 760m and 3100m |
| cardiac output | Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography | 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 | 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 | 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) | 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) | Day 2 at 3100m |
| stroke volume | Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 760m and 3100m |
| stroke volume | Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography | Day 2 at 3100m |
| volumes | Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 760m and 3100m |
| volumes | Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 3100m |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |