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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Chronic Obstructive Pulmonary Disease at Altitude. A Randomized, Placebo-controlled, Double-blind Parallel Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167034
• Other study ID #: 2017-00137F
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: August 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 during exercise 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 during graded cycling on an ergometer by transthoracic echocardiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ACETAZOLAMIDE oral capsule
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
• Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary artery pressure during exercise	Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 3200m
Secondary	pulmonary artery pressure during exercise	Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 760 m and 3200 m
Secondary	cardiac output during exercise	Difference in change of cardiac output during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 3200m
Secondary	cardiac output during exercise	Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 760 m and 3200 m
Secondary	PAP/CO slope during exercise	Difference in change of PAP/CO slope during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 3200m
Secondary	PAP/CO slope during exercise	Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer	Day 2 at 760 m and 3200 m
Secondary	Oxygen saturation	Difference in altitude-induced change during exercise of oxygen saturation between acetazolamide and placebo group, measured by pulse oximeter	Day 2 and 3200 m
Secondary	Oxygen saturation	Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter	Day 2 at 760 m and 3200 m