Altitude Hypoxia Clinical Trial
Official title:
Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Verified date | November 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Healthy men and women, age 40-75 yrs, without any disease and need of medication. - Born, raised and currently living at low altitude (<800m). - Written informed consent. - Kyrgyz ethnicity Exclusion Criteria: - Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. - Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol. - Allergy to acetazolamide and other sulfonamides. |
Country | Name | City | State |
---|---|---|---|
Kyrgyzstan | National Center of Cardiology and Internal Medicine | Bishkek |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov |
Kyrgyzstan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pulmonary artery pressure (PAP) during exercise | Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 3100m | |
Secondary | pulmonary artery pressure during exercise | Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 760 m and 3100 m | |
Secondary | cardiac Output (CO) during exercise | Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 3100m | |
Secondary | cardiac output during exercise | Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 760 m and 3100 m | |
Secondary | PAP/CO slope during exercise | Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 3100m | |
Secondary | PAP/CO slope during exercise | Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer | Day 2 at 760 m and 3100 m | |
Secondary | Oxygen saturation | Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter | Day 2 at 3100m | |
Secondary | Oxygen saturation | Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter | Day 2 at 760 m and 3100 m |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05603689 -
Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude
|
N/A | |
Completed |
NCT03536455 -
Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude
|
Phase 4 | |
Completed |
NCT03536429 -
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude
|
Phase 4 | |
Completed |
NCT03536520 -
Effect of Acetazolamide on Visuo-motor Learning in Lowlanders Older Than 40 Years at Altitude
|
Phase 4 | |
Completed |
NCT03536507 -
Effect of Acetazolamide on Sleep Disordered Breathing in Lowlanders Older Than 40 Years at Altitude
|
Phase 4 | |
Completed |
NCT05468515 -
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
|
||
Active, not recruiting |
NCT05966714 -
Neonatal Cerebral Oxygenation and Electrical Activity at Different Altitude Levels
|
||
Completed |
NCT04075565 -
The Psychophysiological Effect of Simulated and Terrestrial Altitude
|
N/A | |
Not yet recruiting |
NCT05867719 -
The Physiological Effects of Acute and Ramp Simulated Altitude Exposure During Simulated Flight Tasks
|
N/A | |
Active, not recruiting |
NCT04913389 -
Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
|
Phase 3 | |
Active, not recruiting |
NCT03540914 -
Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.
|
Phase 4 | |
Active, not recruiting |
NCT03539367 -
Effect of Acetazolamide on Lung Water Content by Ultrasound in Lowlanders Older Than 40 Years at Altitude
|
Phase 4 | |
Completed |
NCT03368352 -
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
|
Early Phase 1 | |
Enrolling by invitation |
NCT05971290 -
Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude
|
N/A | |
Completed |
NCT04751292 -
HIGH Altitude CArdiovascular REsearch Latin America Population Study
|
||
Completed |
NCT03707249 -
Iron Status and Cardiopulmonary Physiology
|
N/A | |
Completed |
NCT03743610 -
Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
|
N/A | |
Active, not recruiting |
NCT05517044 -
The Pre-acclimatization Augmented Extreme Altitude Expedition
|
N/A | |
Active, not recruiting |
NCT05500014 -
Effect of Altitude on Iron Absorption in Iron Depleted Women
|
N/A |