Right Heart FunctionPhase 3NCT04915365
Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude
A Phase 3 study testing Acetazolamide in people with Right Heart Function and Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Right Heart Function, Chronic Obstructive Pulmonary Disease, Altitude Sickness
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site, 1 recruiting
- Recruiting
National Center of Cardiology and Internal Medicine
Bishkek, 720040
Talant M Sooronbaev, MD
About this study
Official title: Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With Chronic Obstructive Pulmunary Disease (COPD) Traveling to High Altitude
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.
Read the 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.
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acetazolamide, Mountain sickness, Pulmonary Hypertension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Altitude Sickness, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Acetazolamide, oral capsule
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.
PlaceboDrug
Also called Placebo, oral capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | 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. Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (6)
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
Measured: 3 days
Difference in cardiac output
Difference in change of cardiac output evaluated by echocardiography in the acetazolamide compared to the placebo group
Measured: 3 days
Difference in right heart dimensions
Difference in change of right heart dimensions evaluated by echocardiography in the acetazolamide compared to the placebo group
Measured: 3 days
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
Measured: 3 days
Difference in right heart function
Difference in change of fraction area change (FAC) evaluated by echocardiography in the acetazolamide compared to the placebo group
Measured: 3 days
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart FunctionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo-controlled, double-blind
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof, Study chair, University Hospital, Zürich, SwitzerlandTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915365
- Sponsor's protocol ID
- 01-2021-SU-HAECHO
- Status last verified
- Nov 2022
- First submitted
- 31 May 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With Chronic Obstructive Pulmunary Disease (COPD) Traveling to High Altitude
- ClinicalTrials.gov ID
- NCT04915365
- Acronym / sponsor ID
- 01-2021-SU-HAECHO
- Keywords
- Acetazolamide, Mountain sickness, Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideAcetazolamide (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 comparator | Drug: PlaceboPlacebo (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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: Acetazolamide, oral capsuleAcetazolamide (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. | Drug | Acetazolamide |
| PlaceboAlso: Placebo, oral capsulePlacebo (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. | Drug | Placebo |
Primary outcome
Difference in change of pulmonary artery pressure
Time frame: 3 days
Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
6 secondary outcomes
Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude
Time frame: 3 days
Difference in cardiac output
Time frame: 3 days
Difference in right heart dimensions
Time frame: 3 days
Difference in right heart function
Time frame: 3 days
Difference in right heart function
Time frame: 3 days
Difference in right heart function
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Ulrich, Prof study chair
University Hospital, Zürich, Switzerland
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetazolamide in people with Right Heart Function and Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change of pulmonary artery pressure (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.