Effect of acetazolamide on the frequency of high altitude pulmonary edema at 4559 m

Effect of acetazolamide on the incidence of high altitude pulmonary edema at 4559 m - Acetazolamide and HAPE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005166-22-AT

Enrollment

Registered

2018-02-07

Start date

2018-03-26

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer trial at 4459m to investigate the effect of acetazolamide on the incidence of high altitude pulmonary edema. MedDRA version: 20.0 Level: LLT Classification code 10020045 Term: High altitude illness System Organ Class: 100000004863

Interventions

Trade Name: Acemit 250 mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: ACETAZOLAMIDE SODIUM CAS Number: 1424-27-7 Current Sponsor code: M2018 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-64 years - Previous history of high altitude pulmonary edema - Good physical condition - No relevant pathologies upon the pre-examination prior to the study - Written informed consent to participate in the study - Permanent residency below 1000 m - Males and females are included without prioritization - Previous experience in the use of crampons and ice axe Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Acute and chronic lung diseases - Conventional systolic blood pressure (average of two measurements) =150 mmHg and conventional diastolic blood pressure =95 mmHg in untreated or treated subjects - Cardiovascular diseases other than systemic arterial hypertension (coronary heart disease, pulmonary hypertension, heart failure, atrial fibrillation, peripheral artery disease) - Chronic headache / migraine - Diabetes mellitus - Smoking (>6 cigarettes/day) or equivalent nicotine substitutes - Alcohol (>30 g/d) or drug abuse - Obesity (Body Mass Index >30) - Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, pregnancy, lactation) - Sojourn >2000 m within the last 4 weeks before the 1st study day - Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants) - Hypersensitivity to acetazolamide, sulfonamides, or any component of the formulation - Blood donation within the last 2 month before the 1st study da

Design outcomes

Primary

Measure	Time frame
Main Objective: Does acetazolamide reduce the incidence of high altitude pulmoanry edema after rapid and active ascent to 4559 m?;Secondary Objective: 1. Does acetazolamide reduce the height of pulmonary artery pressure after rapid, active ascent to 4559 m? 2. Does acetazolamide reduce the incidence of acute mountain sickness after rapid, active ascent to 4559 m? ;Primary end point(s): Incidence of high altitude pulmonary edema;Timepoint(s) of evaluation of this end point: After 72 hours at 4559 m	—

Measure

Time frame

Main Objective: Does acetazolamide reduce the incidence of high altitude pulmoanry edema after rapid and active ascent to 4559 m?;Secondary Objective: 1. Does acetazolamide reduce the height of pulmonary artery pressure after rapid, active ascent to 4559 m? 2. Does acetazolamide reduce the incidence of acute mountain sickness after rapid, active ascent to 4559 m? ;Primary end point(s): Incidence of high altitude pulmonary edema;Timepoint(s) of evaluation of this end point: After 72 hours at 4559 m

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Height of pulmonary artery systolic pressure 2. Incidence of acute mountain sickness;Timepoint(s) of evaluation of this end point: After 72 hours at 4559 m	—

Countries

Austria

Contacts

Public ContactSekretariat

UK für Anästhesiologie und allgemeine Intensivmedizin

ma.berger@salk.at0043057255 57794

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026