Pulmonary HypertensionNCT03195959
Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Hypoxia and Hyperoxia
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jun 2017to 1 May 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that come to our PH referral center for evaluation of PH and undergo a clinically indicated right heart catheterisation.
Who may be able to join
- clinically indicated right heart catheterisation
- diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension
Who cannot join
- hemodynamically unstable
- partial pressure of Oxygen < 7.3kPa
- no informed consent
- pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
UniversityHospital Zurich, Department of Pulmonology
Zurich, 8091
About this study
Official title: Effect of Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension
Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel.
Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.
- Conditions
- Pulmonary Hypertension
- Being tested
- Hypoxia and Hyperoxia
- Keywords
- Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Hypoxia, Hyperoxia
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia and HyperoxiaOther
10 minutes of breathing a gas mixture with FiO2 0.16 via a tight fitting mask. After 10 minutes of breathing ambient air (normoxia), patients were exposed to hyperoxia (FiO2 1.0) for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PH-Patients | Patients with mean pulmonary artery pressure >25mmHg and a pulmonary arterial wedge pressure <15mmHg during right heart catheterisation, which are diagnosed as having pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Receives: Other: Hypoxia and Hyperoxia | |
| Control group | Patients with clinically indicated right heart catheterisation (because of dyspnea or other signs of PH), but had no PH (no elevated mean pulmonary artery pressure (mPAP <20mmHg)). Receives: Other: Hypoxia and Hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia
Measured: Day 1
Secondary outcomes (4)
change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia
Measured: Day 1
change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia
Measured: Day 1
change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia
Measured: Day 1
change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start22 Jun 2017
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich Somaini, Prof. Dr., Principal investigator, UniversityHospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195959
- Sponsor's protocol ID
- KEK-ZH-Nr. 2016-02136
- Status last verified
- Nov 2022
- First submitted
- 20 Jun 2017
- 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 Normobaric Hypoxia and Hyperoxia on Pulmonary Hemodynamics in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03195959
- Acronym / sponsor ID
- KEK-ZH-Nr. 2016-02136
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Hypoxia, Hyperoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 22 Jun 2017 (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.
Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel.
Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH-Patients | – | Other: Hypoxia and HyperoxiaPatients with mean pulmonary artery pressure >25mmHg and a pulmonary arterial wedge pressure <15mmHg during right heart catheterisation, which are diagnosed as having pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. |
| Control group | – | Other: Hypoxia and HyperoxiaPatients with clinically indicated right heart catheterisation (because of dyspnea or other signs of PH), but had no PH (no elevated mean pulmonary artery pressure (mPAP <20mmHg)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that come to our PH referral center for evaluation of PH and undergo a clinically indicated right heart catheterisation.
Key inclusion criteria (2 listed)
- clinically indicated right heart catheterisation
- diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension
Key exclusion criteria (4 listed)
- hemodynamically unstable
- partial pressure of Oxygen < 7.3kPa
- no informed consent
- pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015
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 |
|---|---|---|
| Hypoxia and Hyperoxia10 minutes of breathing a gas mixture with FiO2 0.16 via a tight fitting mask. After 10 minutes of breathing ambient air (normoxia), patients were exposed to hyperoxia (FiO2 1.0) for 10 minutes. | Other | Control group, PH-Patients |
Primary outcome
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia
Time frame: Day 1
4 secondary outcomes
change of mean pulmonary artery pressure under hyperoxia in comparison to normoxia and hyperoxia
Time frame: Day 1
change of the cardiac output under hyperoxia in comparison to normoxia and hyperoxia
Time frame: Day 1
change of the partial pressure of carbon dioxide under hyperoxia in comparison to normoxia and hyperoxia
Time frame: Day 1
change of the partial pressure of oxygen under hyperoxia in comparison to normoxia and hyperoxia
Time frame: Day 1
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 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 Somaini, Prof. Dr. 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?
An observational study of Pulmonary Hypertension, 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 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 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change of pulmonary vascular resistance during hypoxia in comparison to normoxia and hyperoxia (time frame: Day 1). 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; AzTrials last refreshed its copy on 7 Nov 2026.