Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders Older Than 40 Years at Altitude.

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Brief Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Difference in pulmonary artery pressure evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group

Condition

Altitude Hypoxia

Intervention

ACETAZOLAMIDE oral capsule

Study Arms / Comparison Groups

 ACETAZOLAMIDE oral capsule
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

400

Start Date

June 1, 2018

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

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.
      

Gender

All

Ages

40 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Konrad E Bloch, MD, , 

Location Countries

Kyrgyzstan

Location Countries

Kyrgyzstan

Administrative Informations


NCT ID

NCT03540914

Organization ID

2018-01-8/305E


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Study Sponsor

Konrad E Bloch, MD, Study Chair, University Hospital, Zürich


Verification Date

January 2020