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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

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

NCT ID

NCT04915365

First Posted

May 31, 2021

Last Updated

November 1, 2022

Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine, Kyrgyz Republic

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Acetazolamide

Other Intervention Name(s)

Acetazolamide, oral capsule

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo, oral capsule

Intervention Description

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

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

silvia.ulrich@usz.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Konrad E. Bloch, Prof

Phone

+41442553828

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

Learn more about this trial

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

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