HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-31

Brief Summary

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Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.

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Detailed Description

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Conditions

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High Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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WOMEN - ACETAZOLAMIDE oral capsule

Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.

MEN - ACETAZOLAMIDE oral capsule

Acetazolamide 250 mg/day (capsules @125 mg; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.

WOMEN - PLACEBO oral capsule

Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.

MEN - PLACEBO oral capsule

Placebo (capsules identically looking as acetazolamide capsules; 1 in the morning, 1 in the evening), orally. Medication starts 24 hours before ascent to 3600 m until the morning after the second night at 3600 m.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.

Interventions

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Acetazolamide

Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.

Intervention Type DRUG

Placebo

Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes