High Altitude Pulmonary HypertensionNCT05131737
Exercise Endurance Time on the 2nd Day at 2500 m High Altitude
A study testing High altitude exposure and Low altitude exposure in people with High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Altitude Pulmonary Hypertension
- What is being tested?
- High altitude exposure and Low altitude exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 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.
About this study
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension
Read the detailed description
Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed
- Conditions
- High Altitude Pulmonary Hypertension
- Being tested
- High altitude exposure, Low altitude exposure
- 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.
High altitude exposureProcedure or surgery
Exposure to 2500m of altitude
Low altitude exposureProcedure or surgery
Exposure to 490 m
| Study group | Role | What they receive |
|---|---|---|
| Constant work-rate at altitude 2500 m above sea level (high altitude) | Experimental | Cycling at high altitude Receives: Procedure: High altitude exposure; Procedure: Low altitude exposure |
| Constant work-rate at altitude 470 m above sea level (low altitude) | Active comparator | Cycling at low altitude Receives: Procedure: High altitude exposure; Procedure: Low altitude exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
cycle constant work-rate exercise test
Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)
Measured: 30 hours
Secondary outcomes (10)
Heart rate
Difference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Ventilation in liters per minute
Difference in cardiorespiratory measurements: Ventilation assessed in liters per minute, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Oxygen uptake
Difference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Oxygen saturation
Difference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Partial pressure or oxygen
Difference in partial pressure of oxygen at the beginning and end of a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Tricuspid pressure gradient
Trans-tricuspid pressure gradient by echocardiography
Measured: 30 hours
Borg dyspnoea scale
Difference in post-exercise Borg dyspnoea and leg fatigue scale during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Measured: 30 hours
Visual analogue scale
Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude
Measured: 30 hours
sit-to-stand test frequency
Difference in baseline in sit-to-stand test frequency of standing up from a chair in a minute at high altitude vs. low altitude
Measured: 30 hours
6 minute walk test
Difference in baseline in 6 minute walk test distance at high altitude vs. low altitude
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 posted23 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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131737
- Sponsor's protocol ID
- OVERALP II C
- 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
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
- NCT05131737
- Acronym / sponsor ID
- OVERALP II C
- Conditions
- High Altitude Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 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
- 23 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.
The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension
Detailed description
Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant work-rate at altitude 2500 m above sea level (high altitude) | Experimental | Procedure: High altitude exposure, Procedure: Low altitude exposureCycling at high altitude |
| Constant work-rate at altitude 470 m above sea level (low altitude) | Active comparator | Procedure: High altitude exposure, Procedure: Low altitude exposureCycling at low 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 |
|---|---|---|
| High altitude exposureExposure to 2500m of altitude | Procedure or surgery | Constant work-rate at altitude 2500 m above sea level (high altitude), Constant work-rate at altitude 470 m above sea level (low altitude) |
| Low altitude exposureExposure to 490 m | Procedure or surgery | Constant work-rate at altitude 2500 m above sea level (high altitude), Constant work-rate at altitude 470 m above sea level (low altitude) |
Primary outcome
cycle constant work-rate exercise test
Time frame: 30 hours
Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)
10 secondary outcomes
Heart rate
Time frame: 30 hours
Ventilation in liters per minute
Time frame: 30 hours
Oxygen uptake
Time frame: 30 hours
Oxygen saturation
Time frame: 30 hours
Partial pressure or oxygen
Time frame: 30 hours
Tricuspid pressure gradient
Time frame: 30 hours
Borg dyspnoea scale
Time frame: 30 hours
Visual analogue scale
Time frame: 30 hours
sit-to-stand test frequency
Time frame: 30 hours
6 minute walk test
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.
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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 High altitude exposure and Low altitude exposure in people with High Altitude 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 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?
cycle constant work-rate exercise test (time frame: 30 hours). 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 11 May 2022.