Hypertension, PulmonaryPhase 2/3ChronicAZANCT02755298
Chronic Clinical Effect of Acetazolamide
A Phase 2/3 study testing Acetazolamide in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- 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
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Nov 2020
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
- Patients have to be in a stable condition, on the same medication for >4 weeks
Who cannot join
- Patients in whom a RHC is clinically not indicated
- pregnant women
- PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Clinical Effect of Acetazolamide in Pulmonary Hypertension
The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.
Read the detailed description
Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. We have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the chronic clinical effects of AZA in PH patients.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Acetazolamide, Placebo
- Keywords
- Treatment Outcome, Acetazolamide
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Twice a day 250 mg acetazolamide for 5 weeks Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Placebo capsule 250 mg (Mannitol) twice a day 5 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in 6 min walk distance
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Secondary outcomes (14)
Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Progressive maximal ramp cardiopulmonary exercise testing
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
cerebral and muscle tissue oxygenation
At the end of both periods (AZA and Placebo) at rest and exercise
Measured: 5 weeks
daily activity
actigraphy
Measured: 5 weeks
morphological and functional parameters of the heart
measured by echocardiography
Measured: 5 weeks
New York Heart Association functional class
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Short-form medical outcome questionnaire (SF-36)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
N-terminal pro-brain natriuretic Peptide (NT-proBNP)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
mean nocturnal oxygen Saturation during ambulatory sleep studies
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
apnea/hypopnea index during ambulatory sleep studies
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Stroop test of cognitive performance
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Trail making test (test of cognitive Performance)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
5 point test (test of cognitive Performance)
At the end of both periods (AZA and Placebo)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, MD, Principal investigator, UniversityHospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755298
- Sponsor's protocol ID
- KEK-ZH-2016-00089-2
- Acronym
- ChronicAZA
- Status last verified
- Dec 2020
- First submitted
- 24 Mar 2016
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lichtblau M, Saxer S, Muller J, Appenzeller P, Berlier C, Schneider SR, Mayer L, Furian M, Schwarz EI, Swenson ER, Bloch KE, Ulrich S. Effect of 5 weeks of oral acetazolamide on patients with pulmonary vascular disease: A randomized, double-blind, cross-over trial. Pulmonology. 2024 Jul-Aug;30(4):362-369. doi: 10.1016/j.pulmoe.2022.11.004. Epub 2023 Jan 11.
PubMed 36639329
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Clinical Effect of Acetazolamide in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02755298
- Acronym / sponsor ID
- ChronicAZA / KEK-ZH-2016-00089-2
- Conditions
- Hypertension, Pulmonary
- Keywords
- Treatment Outcome, Acetazolamide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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 study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.
Detailed description
Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. We have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the chronic clinical effects of AZA in PH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideTwice a day 250 mg acetazolamide for 5 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule 250 mg (Mannitol) twice a day 5 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
- Patients have to be in a stable condition, on the same medication for >4 weeks
Key exclusion criteria (3 listed)
- Patients in whom a RHC is clinically not indicated
- pregnant women
- PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
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 |
|---|---|---|
| Acetazolamide | Drug | Acetazolamide |
| Placebo | Drug | Placebo |
Primary outcome
Difference in 6 min walk distance
Time frame: 5 weeks
At the end of both periods (AZA and Placebo)
14 secondary outcomes
Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF)
Time frame: 5 weeks
Progressive maximal ramp cardiopulmonary exercise testing
Time frame: 5 weeks
cerebral and muscle tissue oxygenation
Time frame: 5 weeks
daily activity
Time frame: 5 weeks
morphological and functional parameters of the heart
Time frame: 5 weeks
New York Heart Association functional class
Time frame: 5 weeks
Short-form medical outcome questionnaire (SF-36)
Time frame: 5 weeks
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Time frame: 5 weeks
N-terminal pro-brain natriuretic Peptide (NT-proBNP)
Time frame: 5 weeks
mean nocturnal oxygen Saturation during ambulatory sleep studies
Time frame: 5 weeks
apnea/hypopnea index during ambulatory sleep studies
Time frame: 5 weeks
Stroop test of cognitive performance
Time frame: 5 weeks
Trail making test (test of cognitive Performance)
Time frame: 5 weeks
5 point test (test of cognitive Performance)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 36639329Lichtblau M, Saxer S, Muller J, Appenzeller P, Berlier C, Schneider SR, Mayer L, Furian M, Schwarz EI, Swenson ER, Bloch KE, Ulrich S. Effect of 5 weeks of oral acetazolamide on patients with pulmonary vascular disease: A randomized, double-blind, cross-over trial. Pulmonology. 2024 Jul-Aug;30(4):362-369. doi: 10.1016/j.pulmoe.2022.11.004. Epub 2023 Jan 11.
- Individual participant dataSharing planned: Undecided
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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, MD principal investigator
UniversityHospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acetazolamide in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Dec 2020. 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 Switzerland. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in 6 min walk distance (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755298, which also lists 1 linked publication.
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 19 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.