Clinical trial NCT04915365: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Right Heart Function
Chronic Obstructive Pulmonary Disease
Altitude Sickness
Keywords: Acetazolamide
Mountain sickness
Pulmonary Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine, Kyrgyz Republic
First posted: 2021-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo-controlled, double-blind
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Difference in change of pulmonary artery pressure
timeFrame: 3 days
Secondary outcomes:
measure: Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude
timeFrame: 3 days
measure: Difference in cardiac output
timeFrame: 3 days
measure: Difference in right heart dimensions
timeFrame: 3 days
measure: Difference in right heart function
timeFrame: 3 days
measure: Difference in right heart function
timeFrame: 3 days
measure: Difference in right heart function
timeFrame: 3 days
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich, Switzerland
name: Silvia Ulrich, Prof
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References: