Clinical trial NCT03173508: Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: right ventricular function
echocardiography
obstructive airway disease
emphysema
acetazolamide
altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-06-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: pulmonary artery pressure
timeFrame: Day 2 at 760m and 3200m
Secondary outcomes:
measure: pulmonary artery pressure
timeFrame: Day 2 at 3200m
measure: cardiac output
timeFrame: Day 2 at 760m and 3200m
measure: cardiac output
timeFrame: Day 2 at 3200m
measure: right heart dimensions
timeFrame: Day 2 at 760m and 3200m
measure: right heart dimensions
timeFrame: Day 2 at 3200m
measure: right heart function
timeFrame: Day 2 at 760m and 3200m
measure: right heart function
timeFrame: Day 2 at 3200m
measure: stroke volume
timeFrame: Day 2 at 760m and 3200m
measure: stroke volume
timeFrame: Day 2 at 3200m
measure: volumes
timeFrame: Day 2 at 760m and 3200m
measure: volumes
timeFrame: Day 2 at 3200m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References: