Pulmonary Vascular DiseaseNCT06003244
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
A study testing 6-minute walk distance (6MWD) test and 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal) in people with Pulmonary Vascular Disease and Pulmonary Artery Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 2840m. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- 6-minute walk distance (6MWD) test and 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 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
None listed.
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 6-minute Walk Distance (6MWD)
The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 2840m.
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 permanently live at HA >2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.
- Conditions
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- 6-minute walk distance (6MWD) test, 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
- Keywords
- Pulmonary Hypertension, Hypoxia, Supplemental Oxygen Therapy, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude, Pulmonary vascular disease
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Hypertension, Pulmonary, Hypoxia, Pulmonary Arterial Hypertension, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk distance (6MWD) testOther
6-minute walk distance (6MWD) test will be performed according to clinical standards
6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)Other
6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)
| Study group | Role | What they receive |
|---|---|---|
| Ambient air | Active comparator | Patient will perform tests on ambient air at 2840 m Receives: Other: 6-minute walk distance (6MWD) test |
| SOT via nasal canula | Experimental | Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care Receives: Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal) |
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 at 2840m
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
Measured: after 6 minute
Secondary outcomes (4)
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Measured: 6 minutes
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Measured: 6 minutes
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
Measured: 6 minutes
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m
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 posted21 Aug 2023
- Study start23 Sep 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.
- Other trials for Pulmonary Vascular DiseaseStudies 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
- None (open label)
- 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
- NCT06003244
- Sponsor's protocol ID
- PVD_HA_SOT_6MWD
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2023
- Last updated
- 5 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 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 6-minute Walk Distance (6MWD)
- ClinicalTrials.gov ID
- NCT06003244
- Acronym / sponsor ID
- PVD_HA_SOT_6MWD
- Conditions
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Hypoxia, Supplemental Oxygen Therapy, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude, Pulmonary vascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Aug 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.
The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 2840m.
Detailed description
Participants 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 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant works as its own perfect control
| Arm | Type | Receives |
|---|---|---|
| Ambient air | Active comparator | Other: 6-minute walk distance (6MWD) testPatient will perform tests on ambient air at 2840 m |
| SOT via nasal canula | Experimental | Other: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| 6-minute walk distance (6MWD) test6-minute walk distance (6MWD) test will be performed according to clinical standards | Other | Ambient air |
| 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal) | Other | SOT via nasal canula |
Primary outcome
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Time frame: after 6 minute
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
4 secondary outcomes
SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
Time frame: 6 minutes
Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
Time frame: 6 minutes
Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
Time frame: 6 minutes
Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- 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, 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 6-minute walk distance (6MWD) test and 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal) in people with Pulmonary Vascular Disease 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 0 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 5 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. 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?
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m (time frame: after 6 minute). 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 5 Oct 2023.