Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 44

Acetazolamide and plasma volume changes at high altitude

Official title: HighCycle Study: Effect of Acetazolamide on Plasma Volume During Acute Exposure to High Altitude in Women and Men

Run by Centre d'Expertise sur l'Altitude EXALT · NCT07118462 · Data updated 2026-11-12

This study will see if acetazolamide helps prevent early plasma volume loss and related altitude symptoms in healthy adults who normally live at low altitude.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 44 Years
SexAll
Enrollment270 (estimated)
SponsorCentre d'Expertise sur l'Altitude EXALT
Academic / other
Locations1 site (Bishkek)
StatusRecruiting
StartedJuly 15, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedAugust 12, 2025
Trial IDNCT07118462 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy, non-smoking men and premenopausal women aged 18–44 who were born, raised, and currently live below 1000 m and can attend the Bishkek study site.

Probably not a fit

Those who are pregnant or nursing, anemic, using excluded hormonal contraceptives, recently traveled to high altitude, or already live at high altitude are unlikely to qualify or see direct benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy, non-smoking men and premenopausal women aged 18–44 who were born, raised, and currently live below 1000 m are enrolled. Participants receive either acetazolamide or a matching placebo and undergo controlled high-altitude exposure with physiological measurements taken during the first 24 hours. Investigators measure plasma volume and hemoglobin concentration to characterize early fluid shifts that occur with hypoxia. Key exclusions include pregnancy or nursing, anemia, recent altitude exposure, and use of most hormonal contraceptives.

Why it matters

Potential benefit: If successful, this could help maintain plasma volume and reduce early altitude-related symptoms like acute mountain sickness for people traveling to high altitude.

How similar studies have gone: Acetazolamide is already used to prevent acute mountain sickness and prior controlled hypoxia studies have shown early plasma volume shifts, but its specific effect on plasma volume during ascent is still being clarified.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any disease 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 (contraceptives (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 it's running

  • National Center for Cardiology and Internal Medicine
    Bishkek, Kyrgyzstan
    Recruiting

Study contacts

  • Principal investigator: Paul Robach, PhD — EXALT (Centre d'Expertise sur l'Altitude), Grenoble, France
  • Study coordinator: Benoit Champigneulle, MD PhD
  • Email: BChampigneulle@chu-grenoble.fr
  • Phone: +33476769288

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.