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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine, Kyrgyz Republic | UNKNOWN |
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The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the effect of acetazolamide on right heart function at rest in lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early signs of altitude-illness.
This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effect of acetazolamide on right heart function in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Experimental | Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m. |
|
| Placebo | Placebo Comparator | Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change of pulmonary artery pressure | Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude | 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 | 3 days |
| Difference in cardiac output |
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Inclusion Criteria:
Men and women, age 35-75 y, living at low altitude (<800 m).
COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry
≥92%, PaCO2 <6 kPa, breathing ambient air at 760 m.
One of the following early signs and/or symptoms of impending altitudeillness identified by self-monitoring during ascent to or stay at 3100 m:
Pulse oximetry SpO2≤84%
Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at least moderate intensity
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Ulrich, Prof | Contact | +41442552220 | silvia.ulrich@usz.ch | |
| Konrad E. Bloch, Prof | Contact | +41442553828 | konrad.bloch@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, Prof | University Hospital, Zürich, Switzerland | Study Chair |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Recruiting | Bishkek | 720040 | Kyrgyzstan |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000532 | Altitude Sickness |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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randomized, placebo-controlled, double-blind
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.
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|
| Placebo | Drug | Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m. |
|
|
Difference in change of cardiac output evaluated by echocardiography in the acetazolamide compared to the placebo group |
| 3 days |
| Difference in right heart dimensions | Difference in change of right heart dimensions evaluated by echocardiography in the acetazolamide compared to the placebo group | 3 days |
| Difference in right heart function | Difference in change of tricuspid annular plane systolic sxcursion (TAPSE) evaluated by echocardiography in the acetazolamide compared to the placebo group | 3 days |
| Difference in right heart function | Difference in change of fraction area change (FAC) evaluated by echocardiography in the acetazolamide compared to the placebo group | 3 days |
| Difference in right heart function | Difference in change of tissue dopple S (TDI S) evaluated by echocardiography in the acetazolamide compared to the placebo group | 3 days |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |