High Altitude Pulmonary HypertensionNCT05264324
Maximal Exercise Capacity at 2500 m of High Altitude
A study testing Maximal Exercise Capacity in people with High Altitude Pulmonary Hypertension and Maximal Exercise Capacity, run by University of Zurich at 1 site in Switzerland.
Trial summary
The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude 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, Maximal Exercise Capacity
- What is being tested?
- Maximal Exercise Capacity
- 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
- 20 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 (Appendix Informed Consent Form)
- 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
The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension
- Being tested
- Maximal Exercise Capacity
- 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.
Maximal Exercise CapacityProcedure or surgery
Maximal Exercise Capacity in incremental ramp exercise tests.
| Study group | Role | What they receive |
|---|---|---|
| High altitude 2500 m above sea level (high altitude) | Experimental | Maximum Exercise Capacity in high altitude Receives: Procedure: Maximal Exercise Capacity |
| Low altitude 470 m above sea level (low altitude) | Active comparator | Maximum Exercise Capacity in low altitude Receives: Procedure: Maximal Exercise Capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal work rate
Change in maximal work rate in Watt at 2500 vs. 490 m
Measured: 30 hours
Secondary outcomes (17)
Heart rate
Change in cardiorespiratory measurements: heart rate during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Ventilation
Change in cardiorespiratory measurements: ventilation during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Oxygen uptake
Change in cardiorespiratory measurements: Oxygen uptake, SpO2, blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Arterial blood oxygenation saturation
Change in cardiorespiratory measurements: Oxygenation (SpO2) during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Blood gases
Change in blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Hemodynamics
Change in hemodynamics assessed by echocardiography
Measured: 30 hours
Borg dyspnoea and leg fatigue scale
Change in post-exercise Borg dyspnoea and leg fatigue scale during a cycle incremental ramp exercise test at high altitude vs. low altitude
Measured: 30 hours
Visual Analogue Scale for dyspnea
Change Visual Analogue Scale at high altitude vs. low altitude according to a 10cm scale from left to right, where the subject has to mark dyspnea with higher values in cm meaning worse dyspnea
Measured: 30 hours
Electro cardiography
Prevalence of abnormal resting electro cardiography (ECG) at high altitude vs. low altitude
Measured: 30 hours
Electro cardiography :ST-segment changes
Difference in ST-segment changes during cycle incremental ramp and constant work-rate exercise tests at high altitude vs. low altitude
Measured: 30 hours
Electro cardiography: ST-segment changes under oxygen
7Difference in ST-segment changes during cycle exercise tests without and with oxygen at high altitude
Measured: 30 hours
Electro cardiography: Clinically relevant ischemia
Incidence of clinically relevant ischemia (>1mm ST-segment depression) during cycle exercise tests at high altitude vs. low altitude
Measured: 30 hour
Electro cardiography: QT-Interval
Change of corrected QT-Interval, during cycle exercise tests at high vs. low altitude
Measured: 30 hours
Electro cardiography: QT-Interval
Change of corrected QRS duration, during cycle exercise tests at high vs. low altitude
Measured: 30 hours
Electro cardiography: PQ-Interval
Change of corrected PQ-Interval, during cycle exercise tests at high vs. low altitude
Measured: 30 hours
Rate pressure product
Change of corrected Rate pressure product, during cycle exercise tests at high vs. low altitude
Measured: 30 hours
Electro cardiography: Cardiac arrhythmia
Incidence of cardiac arrhythmia during cycle exercise tests 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 posted3 Mar 2022
- Study start20 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.
- 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
- Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design
- 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
- NCT05264324
- Sponsor's protocol ID
- OVERALP II D
- 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
- NCT05264324
- Acronym / sponsor ID
- OVERALP II D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 3 Mar 2022 (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 hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design
| Arm | Type | Receives |
|---|---|---|
| High altitude 2500 m above sea level (high altitude) | Experimental | Procedure: Maximal Exercise CapacityMaximum Exercise Capacity in high altitude |
| Low altitude 470 m above sea level (low altitude) | Active comparator | Procedure: Maximal Exercise CapacityMaximum Exercise Capacity in 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 (Appendix Informed Consent Form)
- 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 |
|---|---|---|
| Maximal Exercise CapacityMaximal Exercise Capacity in incremental ramp exercise tests. | Procedure or surgery | High altitude 2500 m above sea level (high altitude), Low altitude 470 m above sea level (low altitude) |
Primary outcome
Maximal work rate
Time frame: 30 hours
Change in maximal work rate in Watt at 2500 vs. 490 m
17 secondary outcomes
Heart rate
Time frame: 30 hours
Ventilation
Time frame: 30 hours
Oxygen uptake
Time frame: 30 hours
Arterial blood oxygenation saturation
Time frame: 30 hours
Blood gases
Time frame: 30 hours
Hemodynamics
Time frame: 30 hours
Borg dyspnoea and leg fatigue scale
Time frame: 30 hours
Visual Analogue Scale for dyspnea
Time frame: 30 hours
Electro cardiography
Time frame: 30 hours
Electro cardiography :ST-segment changes
Time frame: 30 hours
Electro cardiography: ST-segment changes under oxygen
Time frame: 30 hours
Electro cardiography: Clinically relevant ischemia
Time frame: 30 hour
Electro cardiography: QT-Interval
Time frame: 30 hours
Electro cardiography: QT-Interval
Time frame: 30 hours
Electro cardiography: PQ-Interval
Time frame: 30 hours
Rate pressure product
Time frame: 30 hours
Electro cardiography: Cardiac arrhythmia
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.
Related trials for High Altitude Pulmonary Hypertension
Not yet recruiting
Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Healthy Individuals
Healthy, Healthy Adult
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
Not yet recruiting
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
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 Maximal Exercise Capacity in people with High Altitude Pulmonary Hypertension and Maximal Exercise Capacity, 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?
Maximal work rate (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.