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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915365
• Other study ID #: 01-2021-SU-HAECHO
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: Silvia Ulrich, Prof
• Phone: +41442552220
• Email: silvia.ulrich[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Acetazolamide
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
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.

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyz Republic

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days
Secondary	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	3 days
Secondary	Difference in cardiac output	Difference in change of cardiac output evaluated by echocardiography in the acetazolamide compared to the placebo group	3 days
Secondary	Difference in right heart dimensions	Difference in change of right heart dimensions evaluated by echocardiography in the acetazolamide compared to the placebo group	3 days
Secondary	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	3 days
Secondary	Difference in right heart function	Difference in change of fraction area change (FAC) evaluated by echocardiography in the acetazolamide compared to the placebo group	3 days
Secondary	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	3 days