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Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude

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ClinicalTrials.gov Identifier: NCT03173508
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Information provided by (Responsible Party):
Silvia Ulrich Somaini, University of Zurich

Brief Summary:
This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at acute altitude exposure in patients with COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule Phase 4

Detailed Description:

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at rest in lowlanders with chronic obstructive pulmonary disease 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 (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Right ventricular function will be assessed by transthoracic echocardiography.


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 Ventricular Function at Rest in Patients With Chronic Obstructive Pulmonary Disease at Altitude. A Randomized, Placebo-controlled, Double-blind Parallel Trial
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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 3200m until the morning after the second night at 3200m
Drug: ACETAZOLAMIDE oral capsule
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m

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 3200m until the morning after the second night at 3200m.
Drug: Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m




Primary Outcome Measures :
  1. pulmonary artery pressure [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of pulmonary artery pressure (PAP) between acetazolamide and placebo group, measured by transthoracic echocardiography (tricuspid pressure gradient and pulmonary valve acceleration time)


Secondary Outcome Measures :
  1. pulmonary artery pressure [ Time Frame: Day 2 at 3200m ]
    Difference at altitude of pulmonary artery pressure (PAP) between acetazolamide and placebo group, measured by transthoracic echocardiography (tricuspid pressure gradient and pulmonary valve acceleration time)

  2. cardiac output [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography

  3. cardiac output [ Time Frame: Day 2 at 3200m ]
    Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography

  4. right heart dimensions [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography

  5. right heart dimensions [ Time Frame: Day 2 at 3200m ]
    Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography

  6. right heart function [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)

  7. right heart function [ Time Frame: Day 2 at 3200m ]
    Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)

  8. stroke volume [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography

  9. stroke volume [ Time Frame: Day 2 at 3200m ]
    Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography

  10. volumes [ Time Frame: Day 2 at 760m and 3200m ]
    Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography

  11. volumes [ Time Frame: Day 2 at 3200m ]
    Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, age 18-75 yrs.
  • COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
  • Born, raised and currently living at low altitude (<800m).
  • Written informed consent.

Exclusion Criteria:

  • COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
  • Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
  • Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
  • Known renal failure or 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): NCT03173508


Contacts
Contact: Silvia Ulrich, MD +41442552220 silvia.ulrich@usz.ch
Contact: Konrad E Bloch, MD konrad.bloch@usz.ch

Locations
Kyrgyzstan
National Center for Cardiology and Internal Medicine Recruiting
Bishkek, Kyrgyzstan, 720040
Contact: Talant M Sooronbaev, MD    +996 312 625679    Sooronbaev@yahoo.com   
Contact: Konrad E Bloch, MD    +44 255 38 28    konrad.bloch@usz.ch   
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine, Kyrgyzstan
Investigators
Study Chair: Silvia Ulrich, MD University of Zurich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Responsible Party: Silvia Ulrich Somaini, Prof. Dr., University of Zurich
ClinicalTrials.gov Identifier: NCT03173508     History of Changes
Other Study ID Numbers: 2017-00137E
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silvia Ulrich Somaini, University of Zurich:
right ventricular function
echocardiography
obstructive airway disease
emphysema
acetazolamide
altitude

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs