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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
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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.
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.
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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 3200m until the morning after the second night at 3200m |
|
| 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 3200m until the morning after the second night at 3200m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Drug | Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m |
|
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary artery pressure | 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) | Day 2 at 760m and 3200m |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary artery pressure | 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) | Day 2 at 3200m |
| cardiac output |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, MD | University of Zurich | Principal Investigator |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Cardiology and Internal Medicine | Bishkek | 720040 | Kyrgyzstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39756820 | Derived | Preiss H, Mayer L, Furian M, Schneider SR, Muller J, Saxer S, Mademilov M, Titz A, Shehab A, Reimann L, Sooronbaev T, Tanner FC, Bloch KE, Ulrich S, Lichtblau M. Right ventricular strain impairment due to hypoxia in patients with COPD: a post hoc analysis of two randomised controlled trials. Open Heart. 2025 Jan 4;12(1):e002837. doi: 10.1136/openhrt-2024-002837. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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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 3200m |
|
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography |
| Day 2 at 760m and 3200m |
| cardiac output | Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography | Day 2 at 3200m |
| 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 3200m |
| right heart dimensions | Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 3200m |
| 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 3200m |
| right heart function | Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE) | Day 2 at 3200m |
| stroke volume | Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 760m and 3200m |
| stroke volume | Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography | Day 2 at 3200m |
| volumes | Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 760m and 3200m |
| volumes | Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography | Day 2 at 3200m |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |