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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537924
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Altitude Hypoxia Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: ACETAZOLAMIDE oral capsule
Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m

Placebo Comparator: 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
Drug: Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m




Primary Outcome Measures :
  1. pulmonary artery pressure (PAP) during exercise [ Time Frame: Day 2 at 3100m ]
    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


Secondary Outcome Measures :
  1. pulmonary artery pressure during exercise [ Time Frame: Day 2 at 760 m and 3100 m ]
    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

  2. cardiac Output (CO) during exercise [ Time Frame: Day 2 at 3100m ]
    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

  3. cardiac output during exercise [ Time Frame: Day 2 at 760 m and 3100 m ]
    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

  4. PAP/CO slope during exercise [ Time Frame: Day 2 at 3100m ]
    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

  5. PAP/CO slope during exercise [ Time Frame: Day 2 at 760 m and 3100 m ]
    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

  6. Oxygen saturation [ Time Frame: Day 2 at 3100m ]
    Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter

  7. Oxygen saturation [ Time Frame: Day 2 at 760 m and 3100 m ]
    Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537924


Locations
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Kyrgyzstan
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
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Study Chair: Konrad E Bloch, MD University Hospital, Zürich
Study Director: Talant M Sooronbaev,, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Principal Investigator: Michael Furian, M University Hospital, Zürich
Principal Investigator: Silvia Ulrich, MD University Hospital, Zürich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03537924    
Other Study ID Numbers: 2018-01-8/305F
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
healthy participants older than 40 years
right heart function during exercise
prevention
acetazolamide
Additional relevant MeSH terms:
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Altitude Sickness
Hypoxia
Signs and Symptoms, Respiratory
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs