Back to resultsEffect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
ACETAZOLAMIDE oral capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring right ventricular function, echocardiography, obstructive airway disease, emphysema, acetazolamide, altitude
Eligibility 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
Sites / Locations
- National Center for Cardiology and Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACETAZOLAMIDE oral capsule
PLACEBO oral capsule
Arm Description
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
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.
Outcomes
Primary Outcome Measures
pulmonary artery pressure
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
pulmonary artery pressure
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)
cardiac output
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
cardiac output
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
right heart dimensions
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
right heart dimensions
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
right heart function
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
right heart function
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
stroke volume
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
stroke volume
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
volumes
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
volumes
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Full Information
NCT ID
NCT03173508
First Posted
May 23, 2017
Last Updated
August 12, 2019
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
1. Study Identification
Unique Protocol Identification Number
NCT03173508
Brief Title
Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
right ventricular function, echocardiography, obstructive airway disease, emphysema, acetazolamide, altitude
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACETAZOLAMIDE oral capsule
Arm Type
Active Comparator
Arm Description
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
Arm Title
PLACEBO oral capsule
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ACETAZOLAMIDE oral capsule
Intervention Description
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Primary Outcome Measure Information:
Title
pulmonary artery pressure
Description
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)
Time Frame
Day 2 at 760m and 3200m
Secondary Outcome Measure Information:
Title
pulmonary artery pressure
Description
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)
Time Frame
Day 2 at 3200m
Title
cardiac output
Description
Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3200m
Title
cardiac output
Description
Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography
Time Frame
Day 2 at 3200m
Title
right heart dimensions
Description
Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3200m
Title
right heart dimensions
Description
Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 3200m
Title
right heart function
Description
Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time Frame
Day 2 at 760m and 3200m
Title
right heart function
Description
Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)
Time Frame
Day 2 at 3200m
Title
stroke volume
Description
Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3200m
Title
stroke volume
Description
Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography
Time Frame
Day 2 at 3200m
Title
volumes
Description
Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 760m and 3200m
Title
volumes
Description
Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography
Time Frame
Day 2 at 3200m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev, MD
Organizational Affiliation
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Official's Role
Study Director
Facility Information:
Facility Name
National Center for Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude
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