NCT03540914

Brief Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function at rest in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

6.6 years

First QC Date

May 15, 2018

Last Update Submit

March 9, 2023

Conditions

Altitude Hypoxia

Keywords

healthy participants older than 40 yearsright heart functionpreventionacetazolamide

Outcome Measures

Primary Outcomes (1)

  • Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m in the acetazolamide compared to the placebo group

    Difference in change of pulmonary artery pressure evaluated by echocardiography from 760 m baseline measurement to measurement at 3100 m between acetazolamide and placebo groups

    Day 2 at 760m and 3100m

Secondary Outcomes (11)

  • Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group

    Day 2 at 3100m

  • cardiac output

    Day 2 at 760m and 3100m

  • cardiac output

    Day 2 at 3100m

  • right heart dimensions

    Day 2 at 760m and 3100m

  • right heart dimensions

    Day 2 at 3100m

  • +6 more secondary outcomes

Study Arms (2)

ACETAZOLAMIDE oral capsule

ACTIVE COMPARATOR

Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m

Drug: ACETAZOLAMIDE oral capsule

PLACEBO oral capsule

PLACEBO COMPARATOR

Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m.

Drug: Placebo oral capsule

Interventions

ACETAZOLAMIDE oral capsuleDRUG

Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

ACETAZOLAMIDE oral capsule
Placebo oral capsuleDRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

PLACEBO oral capsule

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women, age 40-75 yrs, without any disease and need of medication.
  • Born, raised and currently living at low altitude (\<800m).
  • Written informed consent.
  • Kyrgyz ethnicity

You may not qualify if:

  • Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
  • Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
  • Allergy to acetazolamide and other sulfonamides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

Location

Related Publications (1)

  • Mayer L, Lichtblau M, Furian M, Buergin A, Saxer S, Mademilov M, Bader PR, Schneider SR, Sooronbaev T, Bloch KE, Ulrich S. Effect of Acetazolamide on Pulmonary Hemodynamics and Right Heart Function in Healthy Adults Going to Altitude: A Randomized Controlled Trial. J Am Heart Assoc. 2025 Sep 2;14(17):e041941. doi: 10.1161/JAHA.125.041941. Epub 2025 Aug 29.

    PMID: 40878988DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Konrad E Bloch, MD

    University Hospital, Zürich

    STUDY CHAIR

  • Talant M Sooronbaev,, MD

    National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

    STUDY DIRECTOR

  • Michael Furian, MSc

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

  • Silvia Ulrich, MD

    University Hospital, Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

June 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

KY(1)