Pulmonary HypertensionNCT03637192
Acute Exposure of High Altitude on Cognitive Function
A study testing Low altitude: 470m above sea level and Säntis; 2500m above sea Level in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Low altitude: 470m above sea level and Säntis; 2500m above sea Level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 1 Jan 2019
- 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
- PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
- PH class 1 (PAH) or 4 (CTEPH)
- Stable condition, on the same medication for > 4 weeks
- Patient live permanently at an altitude < 1000m asl.
Who cannot join
- Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- Severe daytime hypercapnia (pCO2 > 6.5 kPa)
- Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
- Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- Residence > 1000m above sea level
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
- Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions
Read the detailed description
Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, pulmonary function test, clinical assessment and blood gas analysis.
Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).
During the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .
The results will be compared to low altitude in Zurich (470m).
- Conditions
- Pulmonary Hypertension
- Being tested
- Low altitude: 470m above sea level, Säntis; 2500m above sea Level
- Keywords
- High Altitude, cognitive function
- Medical subject headings
- Hypertension, Pulmonary, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low altitude: 470m above sea levelOther
Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
Säntis; 2500m above sea LevelOther
Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
| Study group | Role | What they receive |
|---|---|---|
| Order A | Experimental | The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level) Receives: Other: Low altitude: 470m above sea level |
| Order B | Experimental | The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level). Receives: Other: Low altitude: 470m above sea level; Other: Säntis; 2500m above sea Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function test
Change in cognitive function test time during the exposure to High altitude (Säntis ; 2500m above sea level) compared to low altitude (Zurich)
Measured: 1 day at altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Including a baseline assessment and assessments at Low altitude and High altitude
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637192
- Sponsor's protocol ID
- 2018-00455_B6
- Other IDs
- 2018
- Status last verified
- Jan 2020
- First submitted
- 9 Jul 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
- ClinicalTrials.gov ID
- NCT03637192
- Acronym / sponsor ID
- 2018-00455_B6
- Conditions
- Pulmonary Hypertension
- Keywords
- High Altitude, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 17 Aug 2018 (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.
Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions
Detailed description
Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, pulmonary function test, clinical assessment and blood gas analysis.
Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).
During the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .
The results will be compared to low altitude in Zurich (470m).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Including a baseline assessment and assessments at Low altitude and High altitude
| Arm | Type | Receives |
|---|---|---|
| Order A | Experimental | Other: Low altitude: 470m above sea levelThe participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level) |
| Order B | Experimental | Other: Low altitude: 470m above sea level, Other: Säntis; 2500m above sea LevelThe participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
- PH class 1 (PAH) or 4 (CTEPH)
- Stable condition, on the same medication for > 4 weeks
- Patient live permanently at an altitude < 1000m asl.
Key exclusion criteria (7 listed)
- Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- Severe daytime hypercapnia (pCO2 > 6.5 kPa)
- Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
- Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- Residence > 1000m above sea level
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 |
|---|---|---|
| Low altitude: 470m above sea levelAssessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure | Other | Order A, Order B |
| Säntis; 2500m above sea LevelExposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours | Other | Order B |
Primary outcome
Cognitive Function test
Time frame: 1 day at altitude
Change in cognitive function test time during the exposure to High altitude (Säntis ; 2500m above sea level) compared to low altitude (Zurich)
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 7 Jan 2020.
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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. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low altitude: 470m above sea level and Säntis; 2500m above sea Level in people with 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 7 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 7 Jan 2020. 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?
Cognitive Function test (time frame: 1 day at altitude). 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 7 Jan 2020.