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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04915365
Other study ID # 01-2021-SU-HAECHO
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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