Clinical trial NCT03540914: Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.
Official title: Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Altitude Hypoxia
Keywords: healthy participants older than 40 years
right heart function
prevention
acetazolamide
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2018-05-30
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of preventive acetazolamide intake on right heart function at rest in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Day 2 at 760m and 3100m
Secondary outcomes:
measure: Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
timeFrame: Day 2 at 3100m
measure: cardiac output
timeFrame: Day 2 at 760m and 3100m
measure: cardiac output
timeFrame: Day 2 at 3100m
measure: right heart dimensions
timeFrame: Day 2 at 760m and 3100m
measure: right heart dimensions
timeFrame: Day 2 at 3100m
measure: right heart function
timeFrame: Day 2 at 760m and 3100m
measure: right heart function
timeFrame: Day 2 at 3100m
measure: stroke volume
timeFrame: Day 2 at 760m and 3100m
measure: stroke volume
timeFrame: Day 2 at 3100m
measure: volumes
timeFrame: Day 2 at 760m and 3100m
measure: volumes
timeFrame: Day 2 at 3100m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev,, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Zürich
name: Michael Furian, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Zürich
name: Silvia Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
References: