Actively Recruiting
HighCycle Study: Effect of Acetazolamide on Plasma Volume During Acute Exposure to High Altitude in Women and Men
Led by Centre d'Expertise sur l'Altitude EXALT · Updated on 2025-08-12
270
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre d'Expertise sur l'Altitude EXALT
Lead Sponsor
N
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Collaborating Sponsor
AI-Summary
What this Trial Is About
Millions of people who normally live at low altitudes travel to high altitudes for work, tourism, or sports, exposing themselves to low oxygen levels that can cause acute mountain sickness (AMS), a common altitude-related illness. This study focuses on understanding how the body adjusts to low oxygen by examining changes in blood plasma volume and how acetazolamide, a drug used to prevent AMS, affects these changes during rapid ascent to high altitude. Participants will receive either acetazolamide capsules (250 mg per day, split into two doses) or placebo capsules that look identical. The medication begins 24 hours before ascending to 3600 meters and continues until the morning after spending two nights at that altitude. The study compares plasma volume changes in people taking acetazolamide versus placebo during this acute high-altitude exposure. During the study, plasma volume will be measured on the first day at low altitude (760 m) and on the second and third days at high altitude (3600 m). Researchers will also assess differences related to sex, AMS symptoms, hormone levels, and arterial blood gases. The trial includes healthy men and women aged 18 to 44 years who live at low altitude, with monitoring before, during, and after the high-altitude exposure to understand physiological responses and treatment effects.
CONDITIONS
Brief Title
HighCycle Study: Acetazolamide, High Altitude and Plasma Volume
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy, non-smoking men and women aged 18-44 years without any disease or need for regular medication, including oral contraceptives
- Body Mass Index (BMI) greater than 18 kg/m2 and less than 30 kg/m2
- Born, raised, and currently living at altitudes below 1000 meters
- Written informed consent provided
- Premenopausal women with a regular menstrual cycle (eumenorrheic)
You will not qualify if you...
- Use of contraceptives other than oral contraceptives (e.g., hormonal intrauterine device, vaginal ring, subcutaneous injections or implants)
- Pregnancy or breastfeeding
- Anemia with hemoglobin concentration less than 10 g/dl
- Any altitude trip within 4 weeks before the study
- Allergy to acetazolamide or other sulfonamides
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours before ascent
Participants take acetazolamide or placebo capsules twice daily starting 24 hours before ascent to 3600 meters.
1 baseline visit
Duration - Approximately 3 days
Participants continue taking the assigned capsules twice daily until the morning after the second night at 3600 meters.
Visits on Day 1 at 760 m, and Days 2 and 3 at 3600 m
Trial Site Locations
Total: 1 location
1
National Center for Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Actively Recruiting
Research Team
B
Benoit Champigneulle, MD PhD
P
Paul Robach, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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