Effect of Acetazolamide on Pulmonary Artery Pressure in Women and Men at High Altitude
HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
This study tests if a medication called acetazolamide can help prevent altitude-related problems by lowering blood pressure in the lungs for healthy men and women traveling to high altitudes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Bishkek, Bishkek) |
| Trial ID | NCT06498505 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of acetazolamide on pulmonary artery pressure in healthy men and women traveling to an altitude of 3600 meters. Participants will be randomly assigned to receive either acetazolamide or a placebo. The study specifically focuses on comparing the effects between genders, particularly in premenopausal women. The trial aims to gather data on how this medication can help prevent altitude-related complications.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-smoking men and women aged 18-44 who live at lower altitudes and meet specific health criteria.
Not a fit: Patients who are pregnant, nursing, or have certain health conditions or recent altitude exposure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective prevention strategies for high altitude-related health issues, particularly for women.
How similar studies have performed: While studies on acetazolamide have been conducted, this specific focus on gender differences at high altitude is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bishkek, Bishkek
- National Center for Cardiology and Internal Medicine — Bishkek, Bishkek, Kyrgyzstan (Recruiting)
Study contacts
- Study coordinator: Silvia Ulrich, Prof. Dr.
- Email: silvia.ulrich@usz.ch
- Phone: +41442552838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.