Pulmonary HypertensionNCT03637179
Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo) Under Exercise
A study testing Assessment at Low Altitude (470m above sea level) and Exposure to High Altitude (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 Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise. 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?
- Assessment at Low Altitude (470m above sea level) and Exposure to High Altitude (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 Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise.
Read the detailed description
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), 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).
Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.
- Conditions
- Pulmonary Hypertension
- Being tested
- Assessment at Low Altitude (470m above sea level), Exposure to High Altitude (2500m above sea level)
- Keywords
- High Altitude, Pulmonary artery pressure, Echocardiography, Right heart function, exercise
- Medical subject headings
- Hypertension, Pulmonary, Altitude Sickness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment at Low Altitude (470m above sea level)Other
Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
Exposure to High Altitude (2500m above sea level)Other
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: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m 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: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m above sea level) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Assessment at High Altitude (2500m) during exercise
Pulmonary artery pressure will be measured by echo (TTE) under exercise.
Measured: 1 day at altitude
Secondary outcomes (1)
Echocardiographic right heart assessment at High Altitude (2500m) during exercise
The right heart function (fac, D-Shaping, etc.) will be assessed by echocardiography (TTE) under exercise
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment 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
- NCT03637179
- Sponsor's protocol ID
- 2018-00455_B4
- 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
- NCT03637179
- Acronym / sponsor ID
- 2018-00455_B4
- Conditions
- Pulmonary Hypertension
- Keywords
- High Altitude, Pulmonary artery pressure, Echocardiography, Right heart function, exercise
- 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 Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise.
Detailed description
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), 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).
Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment Including a baseline assessment and assessments at Low altitude and High altitude
| Arm | Type | Receives |
|---|---|---|
| Order A | Experimental | Other: Assessment at Low Altitude (470m above sea level), Other: Exposure to High Altitude (2500m above sea level)The 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: Assessment at Low Altitude (470m above sea level), Other: Exposure to High Altitude (2500m above sea level)The 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 |
|---|---|---|
| Assessment at Low Altitude (470m above sea level)Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure | Other | Order A, Order B |
| Exposure to High Altitude (2500m above sea level)Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours | Other | Order A, Order B |
Primary outcome
Echocardiographic Assessment at High Altitude (2500m) during exercise
Time frame: 1 day at altitude
Pulmonary artery pressure will be measured by echo (TTE) under exercise.
1 secondary outcome
Echocardiographic right heart assessment at High Altitude (2500m) during exercise
Time frame: 1 day at altitude
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 Assessment at Low Altitude (470m above sea level) and Exposure to High Altitude (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?
Echocardiographic Assessment at High Altitude (2500m) during exercise (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.