Pulmonary Vascular DiseaseNCT07777445
Exercise Performance on Ambient Air vs. Low-Flow Liquid Oxygen Therapy in Pulmonary Vascular Disease (PVD)
A study testing 6-minute walk distance (6MWD) test on ambient conditions and 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) in people with Pulmonary Vascular Disease and Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Silvia Ulrich Somaini at 1 site in Switzerland.
Trial summary
The investigators aim to study the effect of liquid oxygen therapy (4l/min, nasal) )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 Disease, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- 6-minute walk distance (6MWD) test on ambient conditions and 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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), chronic obstructive pulmonary disease (COPD) with emphysema, COPD without emphysema, or interstitial lung disease
- 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 PaO2 < 6.9 kPa
- Inability or contraindications to undergo the investigated intervention
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Flow Oxygen Therapy in Patients With Exercise Induced Desaturation Due to Pulmonary Disease
The investigators aim to study the effect of liquid oxygen therapy (4l/min, nasal) )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 nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under ambient air.
- Conditions
- Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)
- Being tested
- 6-minute walk distance (6MWD) test on ambient conditions, 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)
- Keywords
- Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, 6-Minute Walk 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 conditionsOther
6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
6-minute walk distance (6MWD) test with supplemental oxygen (LOX)Other
6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal)
| Study group | Role | What they receive |
|---|---|---|
| Ambient air | Experimental | Patient will be assessed at University Hospital Zurich Receives: Other: 6-minute walk distance (6MWD) test on ambient conditions |
| Liquid oxygen therapy via nasal canula | Active comparator | Supplemental Liquid Oxygen Therapy (LOX) at approximately 4l/min will be provided via nasal canula from a small oxygen tank at University Hospital Zurich to perform clinical assessments. Receives: Other: 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) |
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 supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air
Measured: Distance will be measured at the end of 6 minutes from the 6MWT
Secondary outcomes (5)
SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with LOX approximately 4l /min vs. ambient air
Measured: 6 minutes
Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Change of heart rate (bpm) at rest and at peak 6MWD with LOX vs. ambient air
Measured: 6 minutes
Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air
Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with LOX vs. ambient air
Measured: 6 minutes
Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWT with LOX vs. ambient air
Measured: 6 minutes
Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Change of blood pressure (mmHg) at rest and at peak 6MWD with LOX vs. ambient air
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular DiseaseStudies of the same condition, open and under way.
- 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 serves as its own control
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silvia Ulrich Somaini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvia Ulrich Somaini, University of Zurich
- Investigators
- Silvia Ulrich, Prof. Dr. med., Principal investigator, University Hospital Zurich, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777445
- Sponsor's protocol ID
- 6MWTdesat_PVD_6MWD_LOX
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 9 Sep 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. 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 Flow Oxygen Therapy in Patients With Exercise Induced Desaturation Due to Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07777445
- Acronym / sponsor ID
- 6MWTdesat_PVD_6MWD_LOX
- Conditions
- Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)
- Keywords
- Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, 6-Minute Walk Distance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Silvia Ulrich SomainiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Aug 2026 (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 liquid oxygen therapy (4l/min, nasal) )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 nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under ambient air.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant serves as its own control
| Arm | Type | Receives |
|---|---|---|
| Ambient air | Experimental | Other: 6-minute walk distance (6MWD) test on ambient conditionsPatient will be assessed at University Hospital Zurich |
| Liquid oxygen therapy via nasal canula | Active comparator | Other: 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)Supplemental Liquid Oxygen Therapy (LOX) at approximately 4l/min will be provided via nasal canula from a small oxygen tank at University Hospital Zurich to perform clinical assessments. |
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), chronic obstructive pulmonary disease (COPD) with emphysema, COPD without emphysema, or interstitial lung disease
- 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 (3 listed)
- - Severe hypoxemia needing supplemental oxygen therapy defined as PaO2 < 6.9 kPa
- Inability or contraindications to undergo the investigated intervention
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability 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 conditions6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards | Other | Ambient air |
| 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal) | Other | Liquid oxygen therapy via nasal canula |
Primary outcome
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
Time frame: Distance will be measured at the end of 6 minutes from the 6MWT
Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air
5 secondary outcomes
SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Time frame: 6 minutes
Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Time frame: 6 minutes
Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air
Time frame: 6 minutes
Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Time frame: 6 minutes
Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air
Time frame: 6 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
Silvia Ulrich, Prof. Dr. med. 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 conditions and 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) in people with Pulmonary Vascular Disease and Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Silvia Ulrich Somaini 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 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof. Dr. med. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. 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: Distance will be measured at the end of 6 minutes from the 6MWT). 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 9 Sep 2026.