Hypertension, PulmonaryPhase 2/3AcuteAZANCT02755259
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
A Phase 2/3 study testing Acetazolamide in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC). 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2017to 5 Apr 2019
- 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 RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
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
To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).
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. The investigators 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 acute hemodynamic clinical effects of AZA in PH patients.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acetazolamide, Hemodynamics
- 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 | Diamox 500mg i.v. (1x) Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Placebo Saline injection (1x) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)
At the end of phase at rest
Measured: 60 minutes
PVR AZA vs. Placebo (exercise)
At the end of phase at exercise
Measured: 60 minutes
PVR AZA vs. Placebo (hypoxia)
At the end of phase under hypoxia
Measured: 60 minutes
Secondary outcomes (10)
partial pressure of the oxygen
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
Oxygen uptake
Measured: 15 minutes
minute ventilation
Measured: 15 minutes
arterial oxygenation
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
tissue oxygenation
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
mean pulmonary arterial pressure
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
cardiac output
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
cardiac index
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
pulmonary wedge pressure
At the end of each phase (rest, exercise and hypoxia)
Measured: 60 minutes
Borg scale dyspnea and leg effort
Measured: 15 minutes
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 start1 Jan 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
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
- 33 participants (actual)
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
- NCT02755259
- Sponsor's protocol ID
- KEK-ZH-2016-00089
- Acronym
- AcuteAZA
- Status last verified
- Aug 2019
- First submitted
- 24 Mar 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Duknic M, Lichtblau M, Saxer S, Berlier C, Schneider SR, Schwarz EI, Carta AF, Furian M, Bloch KE, Ulrich S. Comparison of Repetitive Cardiac Output Measurements at Rest and End-Exercise by Direct Fick Using Pulse Oximetry vs. Blood Gases in Patients With Pulmonary Hypertension. Front Med (Lausanne). 2021 Nov 23;8:776956. doi: 10.3389/fmed.2021.776956. eCollection 2021.
PubMed 34888330
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02755259
- Acronym / sponsor ID
- AcuteAZA / KEK-ZH-2016-00089
- Conditions
- Hypertension, Pulmonary
- Keywords
- Acetazolamide, Hemodynamics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (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.
To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).
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. The investigators 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 acute hemodynamic 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: AcetazolamideDiamox 500mg i.v. (1x) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Saline injection (1x) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
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
Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)
Time frame: 60 minutes
At the end of phase at rest
PVR AZA vs. Placebo (exercise)
Time frame: 60 minutes
At the end of phase at exercise
PVR AZA vs. Placebo (hypoxia)
Time frame: 60 minutes
At the end of phase under hypoxia
10 secondary outcomes
partial pressure of the oxygen
Time frame: 60 minutes
Oxygen uptake
Time frame: 15 minutes
minute ventilation
Time frame: 15 minutes
arterial oxygenation
Time frame: 60 minutes
tissue oxygenation
Time frame: 60 minutes
mean pulmonary arterial pressure
Time frame: 60 minutes
cardiac output
Time frame: 60 minutes
cardiac index
Time frame: 60 minutes
pulmonary wedge pressure
Time frame: 60 minutes
Borg scale dyspnea and leg effort
Time frame: 15 minutes
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 13 Aug 2019.
- Derived from this study: PubMed 34888330Duknic M, Lichtblau M, Saxer S, Berlier C, Schneider SR, Schwarz EI, Carta AF, Furian M, Bloch KE, Ulrich S. Comparison of Repetitive Cardiac Output Measurements at Rest and End-Exercise by Direct Fick Using Pulse Oximetry vs. Blood Gases in Patients With Pulmonary Hypertension. Front Med (Lausanne). 2021 Nov 23;8:776956. doi: 10.3389/fmed.2021.776956. eCollection 2021.
- 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 1 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 13 Aug 2019. 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?
Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest) (time frame: 60 minutes). The study lists 3 primary outcomes in all. 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 NCT02755259, 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 13 Aug 2019.