High Altitude Pulmonary HypertensionNCT05112172
Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
A study testing Oxygen Therapy in people with High Altitude Pulmonary Hypertension and Oxygen Therapy, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Altitude Pulmonary Hypertension, Oxygen Therapy
- What is being tested?
- Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Oct 2021to 15 Apr 2022
- 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
- Informed consent as documented by signature
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Who cannot join
- resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
Read the detailed description
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
- Being tested
- Oxygen Therapy
- Medical subject headings
- Pulmonary edema of mountaineers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyOther
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
| Study group | Role | What they receive |
|---|---|---|
| Oxygen Therapy | Experimental | Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude Receives: Other: Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from ARAHE
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
Measured: 30 hours
Secondary outcomes (10)
Constant work-rate exercise time
Difference with oxygen therapy at high altitude vs. low altitude in constant work-rate exercise time cycle exercise test at 75% Wmax at low altitude
Measured: 30 hours
Maximum work-rate in incremental ramp cycle exercise tests
Difference with oxygen therapy at high altitude vs. low altitude in maximal exercise capacity during a incremental ramp cycle exercise test
Measured: 30 hours
Hemodynamics
Difference with oxygen therapy at high altitude vs. low altitude in hemodynamics assessed by echocardiography at rest including pulmonary artery pressure, cardiac output, pulmonary vascular resistance and right heart function assessed as tricuspid plane systolic excursion and fractional area change.
Measured: 30 hours
Borg dyspnoea scale
Difference with oxygen therapy at high altitude vs. low altitude baseline in post-exercise Borg dyspnoea scale going from 1-10 scores with higher values meaning worse dyspnea
Measured: 30 hours
Visual Analogue Scale
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Visual Analogue Scale for dyspnoea, a 10cm line from left to right where patients have to add a cross-line with higher values meaning better feeling.
Measured: 30 hours
Cognitive testing
Difference with oxygen therapy at high altitude vs. low altitude baseline in cognitive function tests
Measured: 30 hours
sit-to-stand test
Difference with oxygen therapy at high altitude vs. low altitude baseline in sit-to-stand test
Measured: 30 hours
Sleep disordered breathing
Difference with oxygen therapy at high altitude vs. low altitude in sleep disordered breathing
Measured: 30 hours
6 minute walk test
Difference with oxygen therapy at high altitude vs. low altitude in 6 minute walk test
Measured: 30 hours
Acute Mountain Sickness Score
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Lake Louise acute mountain sickness score going from 0-12 points with mild AMS as 3-5 points, moderate AMS as 6-9 points, and severe AMS as 10-12 points.
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start18 Oct 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
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 High Altitude 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112172
- Sponsor's protocol ID
- OVERALP II B
- Status last verified
- May 2022
- First submitted
- 14 Oct 2021
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schneider SR, Muller J, Bauer M, Mayer L, Luond L, Ulrich T, Furian M, Forrer A, Carta A, Schwarz EI, Bloch KE, Lichtblau M, Ulrich S. Overnight exposure to high altitude in pulmonary hypertension: adverse events and effect of oxygen therapy. Eur Heart J. 2024 Jan 27;45(4):309-311. doi: 10.1093/eurheartj/ehad789. No abstract available.
PubMed 38079468
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
- ClinicalTrials.gov ID
- NCT05112172
- Acronym / sponsor ID
- OVERALP II B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 8 Nov 2021 (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 whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
Detailed description
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen Therapy | Experimental | Other: Oxygen TherapyOxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent as documented by signature
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Key exclusion criteria (4 listed)
- resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
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 |
|---|---|---|
| Oxygen TherapyOxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude | Other | Oxygen Therapy |
Primary outcome
Recovery from ARAHE
Time frame: 30 hours
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
10 secondary outcomes
Constant work-rate exercise time
Time frame: 30 hours
Maximum work-rate in incremental ramp cycle exercise tests
Time frame: 30 hours
Hemodynamics
Time frame: 30 hours
Borg dyspnoea scale
Time frame: 30 hours
Visual Analogue Scale
Time frame: 30 hours
Cognitive testing
Time frame: 30 hours
sit-to-stand test
Time frame: 30 hours
Sleep disordered breathing
Time frame: 30 hours
6 minute walk test
Time frame: 30 hours
Acute Mountain Sickness Score
Time frame: 30 hours
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 11 May 2022.
- Derived from this study: PubMed 38079468Schneider SR, Muller J, Bauer M, Mayer L, Luond L, Ulrich T, Furian M, Forrer A, Carta A, Schwarz EI, Bloch KE, Lichtblau M, Ulrich S. Overnight exposure to high altitude in pulmonary hypertension: adverse events and effect of oxygen therapy. Eur Heart J. 2024 Jan 27;45(4):309-311. doi: 10.1093/eurheartj/ehad789. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Therapy in people with High Altitude Pulmonary Hypertension and Oxygen Therapy, 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 11 May 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?
Recovery from ARAHE (time frame: 30 hours). 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 NCT05112172, 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 11 May 2022.