Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude

University of Zurich100 enrolled

Overview

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

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis on right heart function during exercise 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Altitude Hypoxia

Interventions

ACETAZOLAMIDE oral capsuleDRUG

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

Placebo oral capsuleDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

pulmonary artery pressure (PAP) during exercise

Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer

Time frame: Day 2 at 3100m

Secondary Outcomes

pulmonary artery pressure during exercise

Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer

Time frame: Day 2 at 760 m and 3100 m

cardiac Output (CO) during exercise

Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer

Time frame: Day 2 at 3100m

cardiac output during exercise

Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer

Time frame: Day 2 at 760 m and 3100 m

PAP/CO slope during exercise

Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer

Time frame: Day 2 at 3100m

PAP/CO slope during exercise

Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer

Data from ClinicalTrials.gov

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