Actively Recruiting

Phase 4
Age: 18Years - 44Years
All Genders
Healthy Volunteers
ID07118462

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

Age: 18Years - 44Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 24 hours before ascent

Participants take acetazolamide or placebo capsules twice daily starting 24 hours before ascent to 3600 meters.

1 baseline visit

Treatment

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

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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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