Pulmonary Vascular DisorderNCT06084559
HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)
A study testing Supplemental oxygen therapy in people with Pulmonary Vascular Disorder and Pulmonary Artery Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Supplemental oxygen therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18-80 years old of both genders,
- Residence > 2500m of altitude
- diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- New York Heart Association (NYHA) functional class I-III
- Provided written informed consent to participate in the study.
Who cannot join
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations, patient permanently living < 2500m.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) <80% on ambient air.
- Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)
- Patient with a non-corrected ventricular septum defect
- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supplemental Oxygen Therapy (SOT) in Patients With Pulmonary Vascular Diseases (PVD) Defined as Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension (PH) Who Permanently Live >2500m on Pulmonary Artery Pressure (PAP) and Other Hemodynamics by Echocardiography
To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.
Read the detailed description
Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.
- Conditions
- Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- Supplemental oxygen therapy, Sham Oxygen therapy
- Keywords
- pulmonary hypertension, hypoxia, supplemental oxygen, 6-minute walk distance
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Hypertension, Pulmonary, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygen therapyOther
Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied
Sham Oxygen therapyOther
Also called Placebo
Patients will reveice pressurized air via a nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Placebo (ambient hypoxic air at 2840m) | Sham comparator | Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir Receives: Other: Sham Oxygen therapy |
| SOT (high flow supplemental oxygen therapy) | Experimental | SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir Receives: Other: Supplemental oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Artery Pressure with SOT vs. placebo
Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Secondary outcomes (8)
Change in Cardiac Output with SOT vs. placebo
Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in right to left heart diameter ratio with SOT vs. placebo
Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in right atrial area with SOT vs. placebo
Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in right heart strain with SOT vs. placebo
Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in ph by arterial blood gases with SOT vs. placebo
Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in PaO2 by arterial blood gases with SOT vs. placebo
Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Change in PaCO2 by arterial blood gases with SOT vs. placebo
Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
Measured: at 15 min of breathing ambient air or supplemental oxygen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start5 Jul 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Vascular DisorderStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant works as its own perfect control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof. Dr., Principal investigator, University Hospital Zurich, Departement of PulmonologyRodrigo Hoyos, Dr., Principal investigator, Carlos Adrade Marin Hospital of Quito, Equador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084559
- Sponsor's protocol ID
- PVD_HA_SOT_PAP
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon request and based on a clear intention reviewed by an ethical review board. Otherwise, we will share anonymized research data after publication on a open access repository according to FAIR principles. Decision about the best suitable plattform is ongoing.
Publications
Muller J, Lichtblau M, Saxer S, Schmucki M, Furian M, Schneider SR, Herzig JJ, Bauer M, Saragoni D, Schwarz EI, Cajamarca E, Hoyos R, Ulrich S. The acute effect of high-dose supplemental oxygen on haemodynamics assessed by echocardiography in patients with pulmonary vascular disease living in Quito at 2850 m: a randomized, single-blind, placebo-controlled crossover trial. Eur Heart J Open. 2024 Dec 2;4(6):oeae097. doi: 10.1093/ehjopen/oeae097. eCollection 2024 Nov.
PubMed 39698150
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Oxygen Therapy (SOT) in Patients With Pulmonary Vascular Diseases (PVD) Defined as Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension (PH) Who Permanently Live >2500m on Pulmonary Artery Pressure (PAP) and Other Hemodynamics by Echocardiography
- ClinicalTrials.gov ID
- NCT06084559
- Acronym / sponsor ID
- PVD_HA_SOT_PAP
- Conditions
- Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Keywords
- pulmonary hypertension, hypoxia, supplemental oxygen, 6-minute walk distance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Oct 2023 (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.
To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.
Detailed description
Patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each participant works as its own perfect control
| Arm | Type | Receives |
|---|---|---|
| Placebo (ambient hypoxic air at 2840m) | Sham comparator | Other: Sham Oxygen therapyAmbient hypoxic air at 2840 m will be applied via a facial mask with reservoir |
| SOT (high flow supplemental oxygen therapy) | Experimental | Other: Supplemental oxygen therapySOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients 18-80 years old of both genders,
- Residence > 2500m of altitude
- diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- New York Heart Association (NYHA) functional class I-III
Key exclusion criteria (8 listed)
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations, patient permanently living < 2500m.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) <80% on ambient air.
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 therapyMobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied | Other | SOT (high flow supplemental oxygen therapy) |
| Sham Oxygen therapyAlso: PlaceboPatients will reveice pressurized air via a nasal cannula | Other | Placebo (ambient hypoxic air at 2840m) |
Primary outcome
Change in Pulmonary Artery Pressure with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
8 secondary outcomes
Change in Cardiac Output with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in right to left heart diameter ratio with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in right atrial area with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in right heart strain with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in ph by arterial blood gases with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in PaO2 by arterial blood gases with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Change in PaCO2 by arterial blood gases with SOT vs. placebo
Time frame: at 15 min of breathing ambient air or supplemental oxygen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Derived from this study: PubMed 39698150Muller J, Lichtblau M, Saxer S, Schmucki M, Furian M, Schneider SR, Herzig JJ, Bauer M, Saragoni D, Schwarz EI, Cajamarca E, Hoyos R, Ulrich S. The acute effect of high-dose supplemental oxygen on haemodynamics assessed by echocardiography in patients with pulmonary vascular disease living in Quito at 2850 m: a randomized, single-blind, placebo-controlled crossover trial. Eur Heart J Open. 2024 Dec 2;4(6):oeae097. doi: 10.1093/ehjopen/oeae097. eCollection 2024 Nov.
- Individual participant dataSharing planned: Yes. Data will be provided upon request and based on a clear intention reviewed by an ethical review board. Otherwise, we will share anonymized research data after publication on a open access repository according to FAIR principles. Decision about the best suitable plattform is ongoing.
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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. Dr. principal investigator
University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos, Dr. principal investigator
Carlos Adrade Marin Hospital of Quito, Equador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental oxygen therapy in people with Pulmonary Vascular Disorder and Pulmonary Artery 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 6 inclusion and 8 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 16 Oct 2023. 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.
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?
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 in Pulmonary Artery Pressure with SOT vs. placebo (time frame: at 15 min of breathing ambient air or supplemental oxygen). 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 NCT06084559, 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 16 Oct 2023.