Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.
- Conditions
- Altitude Hypoxia
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03540914
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACETAZOLAMIDE oral capsule ACETAZOLAMIDE oral capsule 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 PLACEBO oral capsule Placebo oral capsule 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.
- Primary Outcome Measures
Name Time Method 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 Day 2 at 760m and 3100m 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
- Secondary Outcome Measures
Name Time Method cardiac output Day 2 at 3100m Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
right heart dimensions Day 2 at 3100m Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group Day 2 at 3100m Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
right heart function Day 2 at 3100m Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
stroke volume Day 2 at 3100m Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
volumes Day 2 at 3100m Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Trial Locations
- Locations (1)
National Center of Cardiology and Internal Medicine
🇰🇬Bishkek, Kyrgyzstan