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

Primary Purpose

Right Heart Function, Chronic Obstructive Pulmonary Disease, Altitude Sickness

Status
Recruiting
Phase
Phase 3
Locations
Kyrgyzstan
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Right Heart Function focused on measuring Acetazolamide, Mountain sickness, Pulmonary Hypertension

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Center of Cardiology and Internal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm 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.

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Outcomes

Primary Outcome Measures

Difference in change of pulmonary artery pressure
Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group

Secondary Outcome Measures

Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude
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
Difference in cardiac output
Difference in change of cardiac output evaluated by echocardiography in the acetazolamide compared to the placebo group
Difference in right heart dimensions
Difference in change of right heart dimensions evaluated by echocardiography in the acetazolamide compared to the placebo group
Difference in right heart function
Difference in change of tricuspid annular plane systolic sxcursion (TAPSE) evaluated by echocardiography in the acetazolamide compared to the placebo group
Difference in right heart function
Difference in change of fraction area change (FAC) evaluated by echocardiography in the acetazolamide compared to the placebo group
Difference in right heart function
Difference in change of tissue dopple S (TDI S) evaluated by echocardiography in the acetazolamide compared to the placebo group

Full Information

First Posted
May 31, 2021
Last Updated
November 1, 2022
Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine, Kyrgyz Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04915365
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
National Center of Cardiology and Internal Medicine, Kyrgyz Republic

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Function, Chronic Obstructive Pulmonary Disease, Altitude Sickness
Keywords
Acetazolamide, Mountain sickness, Pulmonary Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo-controlled, double-blind
Masking
None (Open Label)
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Acetazolamide, oral capsule
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, oral capsule
Intervention Description
Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.
Primary Outcome Measure Information:
Title
Difference in change of pulmonary artery pressure
Description
Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude
Description
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
Time Frame
3 days
Title
Difference in cardiac output
Description
Difference in change of cardiac output evaluated by echocardiography in the acetazolamide compared to the placebo group
Time Frame
3 days
Title
Difference in right heart dimensions
Description
Difference in change of right heart dimensions evaluated by echocardiography in the acetazolamide compared to the placebo group
Time Frame
3 days
Title
Difference in right heart function
Description
Difference in change of tricuspid annular plane systolic sxcursion (TAPSE) evaluated by echocardiography in the acetazolamide compared to the placebo group
Time Frame
3 days
Title
Difference in right heart function
Description
Difference in change of fraction area change (FAC) evaluated by echocardiography in the acetazolamide compared to the placebo group
Time Frame
3 days
Title
Difference in right heart function
Description
Difference in change of tissue dopple S (TDI S) evaluated by echocardiography in the acetazolamide compared to the placebo group
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Ulrich, Prof
Phone
+41442552220
Email
silvia.ulrich@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad E. Bloch, Prof
Phone
+41442553828
Email
konrad.bloch@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof
Organizational Affiliation
University Hospital, Zürich, Switzerland
Official's Role
Study Chair
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 of Cardiology and Internal Medicine
City
Bishkek
ZIP/Postal Code
720040
Country
Kyrgyzstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talant M Sooronbaev, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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