Pulmonary Vascular DisorderNCT06384534
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
A study testing 6-minute walk distance (6MWD) test on ambient air and 6-minute walk distance test with supplemental oxygen in people with Pulmonary Vascular Disorder and Chronic Thromboembolic Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Vascular Disorder, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- What is being tested?
- 6-minute walk distance (6MWD) test on ambient air and 6-minute walk distance test with supplemental oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2024to 1 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years of age
- Written informed consent
- Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
- Former desaturation under exercise defined as Spo2-decrease >3%
- Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)
Who cannot join
- Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)
- Pregnancy
- Unability or contraindications to undergo the investigated intervention
- Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zürich
Zurich, Canton of Zurich, 8091
About this study
Official title: Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)
The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
Read the detailed description
Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.
The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
- Conditions
- Pulmonary Vascular Disorder, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- Being tested
- 6-minute walk distance (6MWD) test on ambient air, 6-minute walk distance test with supplemental oxygen
- Keywords
- Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Vascular Disease, 6 Minute Walking Distance
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk distance (6MWD) test on ambient airOther
6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
6-minute walk distance test with supplemental oxygenOther
6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)
| Study group | Role | What they receive |
|---|---|---|
| Ambient air | Experimental | Patient will perform tests at University Hospital Zurich Receives: Other: 6-minute walk distance (6MWD) test on ambient air |
| SOT via basal canula | Active comparator | Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich. Receives: Other: 6-minute walk distance test with supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
Measured: after 6 minutes
Secondary outcomes (5)
SpO2 at rest and peak 6MWD with SOT vs. ambient air
Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air
Measured: after 6 minutes
Heart rate at rest and peak 6MWD with SOT vs. ambient air
Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air
Measured: after 6 minutes
Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air
Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air
Measured: 6 minutes
Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air
Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air
Measured: 6 minutes
Blood pressure at rest and peak 6MWD with SOT vs. ambient air
Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air
Measured: after 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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 is its own control
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384534
- Sponsor's protocol ID
- PVD_6MWD_SOT
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2024
- Last updated
- 10 Dec 2025
- 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
Publications
Wick C, Lichtblau M, Titz A, Muller J, Vella A, Bousraou Z, Furian M, Saxer S, Schwarz EI, Ulrich S. Effect of low-flow oxygen therapy on 6 minute walk test in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: a randomized non-inferiority crossover trial. Eur Heart J Open. 2026 Aug 25;6(5):oeag125. doi: 10.1093/ehjopen/oeag125. eCollection 2026 Sep.
PubMed 42688806
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)
- ClinicalTrials.gov ID
- NCT06384534
- Acronym / sponsor ID
- PVD_6MWD_SOT
- Conditions
- Pulmonary Vascular Disorder, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Vascular Disease, 6 Minute Walking Distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 25 Apr 2024 (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.
The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
Detailed description
Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.
The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant is its own control
| Arm | Type | Receives |
|---|---|---|
| Ambient air | Experimental | Other: 6-minute walk distance (6MWD) test on ambient airPatient will perform tests at University Hospital Zurich |
| SOT via basal canula | Active comparator | Other: 6-minute walk distance test with supplemental oxygenSupplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum 18 years of age
- Written informed consent
- Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
- Former desaturation under exercise defined as Spo2-decrease >3%
- Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)
Key exclusion criteria (4 listed)
- Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)
- Pregnancy
- Unability or contraindications to undergo the investigated intervention
- Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
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 |
|---|---|---|
| 6-minute walk distance (6MWD) test on ambient air6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards | Other | Ambient air |
| 6-minute walk distance test with supplemental oxygen6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal) | Other | SOT via basal canula |
Primary outcome
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
Time frame: after 6 minutes
Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
5 secondary outcomes
SpO2 at rest and peak 6MWD with SOT vs. ambient air
Time frame: after 6 minutes
Heart rate at rest and peak 6MWD with SOT vs. ambient air
Time frame: after 6 minutes
Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air
Time frame: 6 minutes
Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air
Time frame: 6 minutes
Blood pressure at rest and peak 6MWD with SOT vs. ambient air
Time frame: after 6 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 10 Dec 2025.
- Derived from this study: PubMed 42688806Wick C, Lichtblau M, Titz A, Muller J, Vella A, Bousraou Z, Furian M, Saxer S, Schwarz EI, Ulrich S. Effect of low-flow oxygen therapy on 6 minute walk test in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: a randomized non-inferiority crossover trial. Eur Heart J Open. 2026 Aug 25;6(5):oeag125. doi: 10.1093/ehjopen/oeag125. eCollection 2026 Sep.
- Individual participant dataSharing planned: Yes. Data will be provided upon request and based on a clear intention reviewed by an ethical review board
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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, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minute walk distance (6MWD) test on ambient air and 6-minute walk distance test with supplemental oxygen in people with Pulmonary Vascular Disorder and Chronic Thromboembolic 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 5 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 10 Dec 2025. 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?
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air (time frame: after 6 minutes). 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 NCT06384534, 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 10 Dec 2025.