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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173508
• Other study ID #: 2017-00137E
• 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 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 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.

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	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)	Day 2 at 760m and 3200m
Secondary	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)	Day 2 at 3200m
Secondary	cardiac output	Difference in altitude-induced change of cardiac output between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3200m
Secondary	cardiac output	Difference at altitude between acetazolamide and placebo group in cardiac output, measured by transthoracic echocardiography	Day 2 at 3200m
Secondary	right heart dimensions	Difference in altitude-induced change of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3200m
Secondary	right heart dimensions	Difference at altitude of right heart dimensions between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 3200m
Secondary	right heart function	Difference in altitude-induced change of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)	Day 2 at 760m and 3200m
Secondary	right heart function	Difference at altitude of right heart function between acetazolamide and placebo group, measured by transthoracic echocardiography (TAPSE)	Day 2 at 3200m
Secondary	stroke volume	Difference in altitude-induced change of stroke volume between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3200m
Secondary	stroke volume	Difference at altitude between acetazolamide and placebo group in stroke volume, measured by transthoracic echocardiography	Day 2 at 3200m
Secondary	volumes	Difference in altitude-induced change of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 760m and 3200m
Secondary	volumes	Difference at altitude of volumes between acetazolamide and placebo group, measured by transthoracic echocardiography	Day 2 at 3200m