Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude

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Brief Title

Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude

Official Title

Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With Chronic Obstructive Pulmunary Disease (COPD) Traveling to High Altitude

Brief Summary

      The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the
      effect of acetazolamide on right heart function at rest in lowlanders with chronic
      obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early
      signs of altitude-illness.
    

Detailed Description

      This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effect
      of acetazolamide on right heart function in lowlanders with chronic obstructive pulmonary
      disease (COPD) travelling to high altitude and developping early symptoms and/or signs of
      impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide
      or placebo treatment during their further stay of 2 days at 3'100 m.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Difference in change of pulmonary artery pressure

Secondary Outcome

 Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude

Condition

Right Heart Function

Intervention

Acetazolamide

Study Arms / Comparison Groups

 Acetazolamide
Description:  Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

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

100

Start Date

June 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women, age 35-75 y, living at low altitude (<800 m).

          -  COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD)
             guidelines, FEV1 40-80% predicted, pulse oximetry

             ≥92%, PaCO2 <6 kPa, breathing ambient air at 760 m.

          -  One of the following early signs and/or symptoms of impending altitudeillness
             identified by self-monitoring during ascent to or stay at 3100 m:

          -  Pulse oximetry SpO2≤84%

          -  Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at
             least moderate intensity

        Exclusion Criteria:

          -  COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see
             above).

          -  Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular
             disease, i.e., unstable arterial hypertension, coronary artery disease; previous
             stroke; obesity (body mass index >35 kg/m2); internal, neurologic, rheumatologic or
             psychiatric disease; current heavy smoking (>20 cigarettes per day).

          -  Renal failure and/or allergy to sulfonamides.

          -  Patients who do not have early signs and/or signs of impending altitudeillness by
             self-monitoring (as defined above) at 3'100m will not be included.
      

Gender

All

Ages

35 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Silvia Ulrich, Prof, +41442552220, [email protected]

Location Countries

Kyrgyzstan

Location Countries

Kyrgyzstan

Administrative Informations


NCT ID

NCT04915365

Organization ID

01-2021-SU-HAECHO


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 National Center of Cardiology and Internal Medicine, Kyrgyz Republic

Study Sponsor

Silvia Ulrich, Prof, Study Chair, University Hospital, Zürich, Switzerland


Verification Date

May 2021