High Altitude
Conditions
Keywords
Women, Hypoxia, Prevention, Acetazolamide, Echocardiography
Brief summary
Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.
Interventions
DRUGAcetazolamide
Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.
DRUGPlacebo
Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.
Sponsors
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University Hospital Heidelberg
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives). * BMI \>18 kg/m2 and \<30 kg/m2 * Born, raised and currently living at altitudes \<1000 m * Written informed consent * Premenopausal women with an eumenorrheic cycle
Exclusion criteria
* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others) * Pregnancy or nursing * Anaemic (haemoglobin concentration \<10g/dl) * Any altitude trip \<4 weks before the study * Allergy to acetazolamide and other sulfonamides
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary artery Pressure (PAP) | Day 2 at 760 m and Day 2 at 3600 m | Sex-related difference in the altitude-induced change in RV/RA in mmHg assessed by echocardiography between acetazolamide and placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung comets | Day 2 at 760 m and Day 2 at 3600 m | Sex-related difference in the altitude-induced change in ultrasound lung comets assessed by echocardiography between acetazolamide and placebo group. |
| Parameters of right heart function | Day 2 at 760 m and Day 2 at 3600 m | Sex-related difference in the altitude-induced change in parameters of right heart function assessed by echocardiography between acetazolamide and placebo group. |
Countries
Kyrgyzstan
Contacts
STUDY_CHAIRSilvia Ulrich, Prof. Dr.
University of Zurich
STUDY_DIRECTORTalant Sooronbaev, Prof. Dr.
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Outcome results
None listed