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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2022 |
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Main ID: |
NCT03537924 |
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Date of registration:
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15/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Acetazolamide on Right Heart Function During Exercise in Lowlanders Older Than 40 Years at Altitude
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Scientific title:
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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 |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03537924 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Kyrgyzstan
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Contacts
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Name:
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Konrad E Bloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Name:
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Michael Furian, M |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Name:
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Talant M Sooronbaev,, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
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Name:
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Silvia Ulrich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Altitude Hypoxia
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Intervention(s)
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Drug: Placebo oral capsule
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Drug: ACETAZOLAMIDE oral capsule
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Primary Outcome(s)
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pulmonary artery pressure (PAP) during exercise
[Time Frame: Day 2 at 3100m]
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Secondary Outcome(s)
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cardiac Output (CO) during exercise
[Time Frame: Day 2 at 3100m]
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Oxygen saturation
[Time Frame: Day 2 at 3100m]
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pulmonary artery pressure during exercise
[Time Frame: Day 2 at 760 m and 3100 m]
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PAP/CO slope during exercise
[Time Frame: Day 2 at 3100m]
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PAP/CO slope during exercise
[Time Frame: Day 2 at 760 m and 3100 m]
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cardiac output during exercise
[Time Frame: Day 2 at 760 m and 3100 m]
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Oxygen saturation
[Time Frame: Day 2 at 760 m and 3100 m]
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Secondary ID(s)
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2018-01-8/305F
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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