Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionPhase 2ExOx-CPETNCT01748474
Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
A Phase 2 study testing Supplemental oxygen via a mask in people with Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension and Chronic Cardiorespiratory Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease
- What is being tested?
- Supplemental oxygen via a mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Jul 2016
- Phase
- Phase 2
- 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
- diagnosis of pulmonary arterial hypertension class I and IV (according to the latest WHO classification scheme of Dana Point 2008)
- on optimized medical therapy and in stable condition for at least 4 week
- desaturate in the 6 minute walking test by at least 4% to values <92%
Who cannot join
- unstable conditions
- pregnant women
- patients with pulmonary venous hypertension
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.
- Conditions
- Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease
- Being tested
- Supplemental oxygen via a mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygen via a maskProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Experimental | Supplemental oxygen will be applied via a mask during CPET Receives: Procedure: Supplemental oxygen via a mask |
| Sham room air | Placebo comparator | Room air will be applied similarly to oxygen Receives: Procedure: Supplemental oxygen via a mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Watt
Measured: 1 day
exercise time
Measured: 1 day
Secondary outcomes (5)
Peak oxygen uptake
Measured: 1 day
Respiratory exchange ratio
Measured: 1 day
ventilatory equivalent of carbon dioxide (VE/VCO2) slope
Measured: 1 day
end-tidal pressures of carbon dioxide (PET CO2)
Measured: 1 day
Changes in arterial blood parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2016
- Study completionJul 2016
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 Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich Somaini, MD, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748474
- Sponsor's protocol ID
- KEK-ZH-NR. 2012-0251
- Acronym
- ExOx-CPET
- Status last verified
- Aug 2016
- First submitted
- 4 Oct 2012
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ulrich S, Hasler ED, Saxer S, Furian M, Muller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.
PubMed 28329240
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01748474
- Acronym / sponsor ID
- ExOx-CPET / KEK-ZH-NR. 2012-0251
- Conditions
- Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Dec 2012 (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.
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Experimental | Procedure: Supplemental oxygen via a maskSupplemental oxygen will be applied via a mask during CPET |
| Sham room air | Placebo comparator | Procedure: Supplemental oxygen via a maskRoom air will be applied similarly to oxygen |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of pulmonary arterial hypertension class I and IV (according to the latest WHO classification scheme of Dana Point 2008)
- on optimized medical therapy and in stable condition for at least 4 week
- desaturate in the 6 minute walking test by at least 4% to values <92%
Key exclusion criteria (4 listed)
- unstable conditions
- pregnant women
- patients with pulmonary venous hypertension
- patients with relevant concomitant lung disease and severe daytime hypoxemia
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 |
|---|---|---|
| Supplemental oxygen via a mask | Procedure or surgery | Sham room air, Supplemental oxygen |
Primary outcome
Watt
Time frame: 1 day
exercise time
Time frame: 1 day
5 secondary outcomes
Peak oxygen uptake
Time frame: 1 day
Respiratory exchange ratio
Time frame: 1 day
ventilatory equivalent of carbon dioxide (VE/VCO2) slope
Time frame: 1 day
end-tidal pressures of carbon dioxide (PET CO2)
Time frame: 1 day
Changes in arterial blood parameters
Time frame: 1 day
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 12 Aug 2016.
- Derived from this study: PubMed 28329240Ulrich S, Hasler ED, Saxer S, Furian M, Muller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.
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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 Somaini, MD principal investigator
University Hospital Zurich, Division of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supplemental oxygen via a mask in people with Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension and Chronic Cardiorespiratory Disease, 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 3 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: finished, as of the sponsor's last update on 12 Aug 2016. 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 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.
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?
Watt (time frame: 1 day). The study lists 2 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 NCT01748474, 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 12 Aug 2016.