High Altitude Pulmonary HypertensionNCT05107700
Altitude Related Adverse Health Effects (ARAHE) in Patients With Precapillary Pulmonary Hypertension During 30h Exposure to 2500m
A study testing Stay at altitude 2500 m above sea level (high altitude) and Stay at altitude 470 m above sea level (low altitude) in people with High Altitude Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
The interest of journeys to high altitude regions for recreational or professional purposes is increasing, also among potentially vulnerable groups including patients with chronic cardiopulmonary diseases such as pulmonary hypertension (PH). 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?
- Stay at altitude 2500 m above sea level (high altitude) and Stay at altitude 470 m above sea level (low altitude)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- 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 interest of journeys to high altitude regions for recreational or professional purposes is increasing, also among potentially vulnerable groups including patients with chronic cardiopulmonary diseases such as pulmonary hypertension (PH). In Switzerland and many other regions worldwide, many settlements and alpine resorts are at altitudes above 1500m and alpine tourism is an important social and economic sector. However, the hypoxic environment at altitude may induce altitude related adverse health effects (ARAHE), including hypoxemia, symptoms of acute mountain sickness (AMS), reduces exercise capacity and increases the pulmonary arterial pressure, which is of particular relevance for patients with chronic hypoxemic respiratory diseases including PH.
On the other hand, advances in disease-targeted medical combination therapies renders PH to the chronic disease groups with many patients surviving for many years with a relatively good quality of live, exercise capacity and low symptom burden. However, data on ARAHE and the exercise capacity of patients with pre-existing PH at altitude is scarce, so that current expert-based guidelines discourage altitude travel for patients with PH. However, we previously showed that the majority of stable PH-patients tolerates normobaric hypoxia or a short trip to 2500m well.
Read more
With this project we aim to get profound clinical and pathophysiological insights into the effects of the hypobaric hypoxic environment at altitude during an overnight stay up to 30 hours on the incidence of ARAHE needing oxygen therapy, exercise capacity, pulmonary hemodynamics and sleep in patients with precapillary PH.
We hope that this new valuable data will provide a basis to better counsel PH-patients for potential risk of altitude sojourns.
Read the detailed description
Background:
Precapillary PH is defined by right heart catheterization as mean PAP (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ⩽15 mmHg along with a pulmonary vascular resistance (PVR) ⩾3 wood units (WU). PH is classified into five major groups according to the clinical presentation and response to vasodilator therapies. In the absence of predominant lung disease, the major precapillary PH forms are pulmonary arterial and chronic thromboembolic PH that are the main pulmonary vascular diseases and hereafter summarized as PH.
The leading symptom in PH is dyspnoea on exertion, impaired exercise performance, daily activity and quality of life.With progression of the disease, worsening hemodynamics may lead to gas exchange disturbances associated with hypoxemia, particularly during exercise and sleep. For a long time, the occurrence of PH was associated with a dismal prognosis progressively leading to right heart failure and death within months to a few years. Although PH is still incurable, recent therapeutic advances including medical or interventional therapies have improved the life expectancy, physical performance and quality of life of PH-patients and many patients seen in our daily practice wish to near-normally participate in professional work and recreational activities.
Globally, leisure time and professional activities at high altitude become increasingly popular exposing millions of people to hypobaric hypoxia annually. The alpine tourism in Europe and in other regions worldwide has a long lasting tradition and a relevant number of people have chosen their resident above 1500m above sea level.
Travel to high altitude and altitude-related adverse health effects (ARAHE):
Many Swiss villages and tourist resorts are located at altitudes between 1000 - 2500 m. In America, Asia and Africa, even large settlements are located at these or even higher altitudes and it is estimated that more than 50 million people permanently live above 2500 m. Accordingly, worldwide, millions of people travel regularly to mountain areas for business or recreation and expose themselves to hypobaric hypoxia during days to weeks or even longer. In addition, traveling by airplane, which has become extremely popular, further increased the number of people that are exposed to a hypoxic environment, as the minimally allowed cabin pressure in commercial air travel is equivalent to 2430 m (8000 ft) of altitude and this is often reached in intercontinental flights.
In healthy individuals, altitude exposure acutely induces hyperventilation by hypoxic chemoreceptor stimulation. This mitigates hypoxemia but promotes sleep disturbing high-altitude periodic breathing. About 50% of lowlanders ascending rapidly to >3000 m suffer from acute mountain sickness (AMS) causing headache, loss of appetite, weakness, fatigue and general discomfort. If AMS is not treated by descent, oxygen or medication, it may progress to life-threatening high altitude cerebral oedema. Furthermore, hypoxic pulmonary vasoconstriction (HPV) leads to an elevated PAP at altitude. In 2-4% of mountaineers climbing to 4559 m, excessive PAP-increase triggers high altitude pulmonary edema (HAPE), a non-cardiogenic pulmonary oedema associated with profound, potentially life-threatening hypoxemia, which is treated by oxygen therapy and may be prevented by phosphodiesterase type-5 inhibitor (PDE5i) administration or dexamethasone.
Contribution of this project to the gap in knowledge of the effects of hypoxia in PH:
The proposed trials will provide novel, robust data on the clinical and pathophysiological effects of exposure to a hypoxic environment in patients with PAH/CTEPH. This study will evaluate for the first time safety and tolerability of altitude exposure including an overnight stay in PH-patients and the effect of supplemental oxygen to reverse ARAHE. Close monitoring of patients including during exercise and sleep will provide insight into hypoxia-induced physiological mechanisms and the time course of altitude adaptation. Due to the special geographical location of Switzerland, we have the unique opportunity to study the response to hypobaric hypoxia in patients with PH in excellently suitable and safe settings in the nearby mountains and provide this important data to the scientific community worldwide for the benefit of many PH-patients and their advising caregivers.
- Conditions
- High Altitude Pulmonary Hypertension
- Being tested
- Stay at altitude 2500 m above sea level (high altitude), Stay at altitude 470 m above sea level (low altitude)
- 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.
Stay at altitude 2500 m above sea level (high altitude)Procedure or surgery
Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m.
Stay at altitude 470 m above sea level (low altitude)Procedure or surgery
Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m.
| Study group | Role | What they receive |
|---|---|---|
| Start with: Stay at altitude 2500 m above sea level (high altitude) | Experimental | Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m. Receives: Procedure: Stay at altitude 2500 m above sea level (high altitude); Procedure: Stay at altitude 470 m above sea level (low altitude) |
| Start with: Stay at altitude 470 m above sea level (low altitude) | Placebo comparator | Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m as comparator. Receives: Procedure: Stay at altitude 2500 m above sea level (high altitude); Procedure: Stay at altitude 470 m above sea level (low altitude) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of altitude-related adverse health effects (ARAHE as defined below) during a sojourn at 2500m, time frame up to 30 h. ARAHE will be defined by any of the following criteria:
- Acute mountain sickness with a Lake Louise score >4 including headache, or AMSc score ≥0.7
- severe hypoxemia defined as: resting SpO2 <75% for >15 min or <80% for >30 min; exercise SpO2 <75% for >5 min and/or criteria for stopping exercise according to guidelines
- intercurrent illness: infection, neurologic, impairment, other new diseases/accidents, requiring medical treatment other than simple measures such as paracetamol
- chest pain and/or ECG signs of cardiac ischemia, syncope, tachy- or bradyarrhythmia, severe hyper- or hypotension accompanied by symptoms
- dyspnoea at rest and/or any discomfort requiring treatment and/or leading to the wish of a patient to return to low altitude or withdraw from the study
Measured: 30 hours
Secondary outcomes (9)
Components of altitude-related adverse health effects
Incidence of individual components of altitude-related adverse health effects
Measured: 30 hours
Severity of symptoms
Severity of symptoms of acute mountain sickness at 2500 m of high altitude measured by the Lake louise score (LLS) (or Acute Mountain Sickness c questionnaire)
Measured: 30 hours
Difference in pulmonary artery pressure
Difference in pulmonary artery pressure assessed by the transtricuspid pressure gradient at rest by echocardiography at high vs. low altitude
Measured: 30 hours
Difference in pulmonary vascular resistance assessed
Difference in pulmonary vascular resistance assessed by the transtricuspid pressure gradient at rest by echocardiography at high vs. low altitude
Measured: 30 hours
Difference in right ventricular function
Difference in right ventricular function impairment by echocardiography at high vs. low altitude
Measured: 30 hours
Resting electrocardiography
Prevalence of abnormal resting electrocardiographies (ECG) at high altitude vs. low altitude
Measured: 30 hours
Exercise electrocardiography
Prevalence of abnormal exercise electrocardiographies (ECG) at high altitude vs. low altitude
Measured: 30 hours
Blood pressure
Difference in blood pressure at high vs. low altitude
Measured: 30 hours
Heart-rate variability
Difference in heart-rate variability at high 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 posted4 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 (3)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
- 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
- NCT05107700
- Sponsor's protocol ID
- OVERALP II A
- Status last verified
- May 2022
- First submitted
- 12 Oct 2021
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller J, Schneider SR, Bauer M, Mayer L, Furian M, Lichtblau M, Ulrich S. The Effect of a 2-Day Stay at High Altitude (2,500 m) on Right Ventricular Afterload and Oxygen Delivery in Patients With Pulmonary Vascular Disease: A Randomized Controlled Crossover Trial. Chest. 2026 Jul 3:S0012-3692(26)00925-6. doi: 10.1016/j.chest.2026.06.032. Online ahead of print.
PubMed 42398808Muller J, Mayer L, Schneider SR, Bauer M, Furian M, Bloch KE, Schwarz EI, Lichtblau M, Silvia U. Pulmonary haemodynamics and right heart function during exercise at high versus low altitude in patients with pulmonary vascular disease: a randomised crossover trial. Heart. 2025 Dec 11;112(1):28-36. doi: 10.1136/heartjnl-2024-325605.
PubMed 40404280Schneider 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
- NCT05107700
- Acronym / sponsor ID
- OVERALP II A
- 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
- 4 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 interest of journeys to high altitude regions for recreational or professional purposes is increasing, also among potentially vulnerable groups including patients with chronic cardiopulmonary diseases such as pulmonary hypertension (PH). In Switzerland and many other regions worldwide, many settlements and alpine resorts are at altitudes above 1500m and alpine tourism is an important social and economic sector. However, the hypoxic environment at altitude may induce altitude related adverse health effects (ARAHE), including hypoxemia, symptoms of acute mountain sickness (AMS), reduces exercise capacity and increases the pulmonary arterial pressure, which is of particular relevance for patients with chronic hypoxemic respiratory diseases including PH.
On the other hand, advances in disease-targeted medical combination therapies renders PH to the chronic disease groups with many patients surviving for many years with a relatively good quality of live, exercise capacity and low symptom burden. However, data on ARAHE and the exercise capacity of patients with pre-existing PH at altitude is scarce, so that current expert-based guidelines discourage altitude travel for patients with PH. However, we previously showed that the majority of stable PH-patients tolerates normobaric hypoxia or a short trip to 2500m well.
With this project we aim to get profound clinical and pathophysiological insights into the effects of the hypobaric hypoxic environment at altitude during an overnight stay up to 30 hours on the incidence of ARAHE needing oxygen therapy, exercise capacity, pulmonary hemodynamics and sleep in patients with precapillary PH.
We hope that this new valuable data will provide a basis to better counsel PH-patients for potential risk of altitude sojourns.
Detailed description
Background:
Precapillary PH is defined by right heart catheterization as mean PAP (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ⩽15 mmHg along with a pulmonary vascular resistance (PVR) ⩾3 wood units (WU). PH is classified into five major groups according to the clinical presentation and response to vasodilator therapies. In the absence of predominant lung disease, the major precapillary PH forms are pulmonary arterial and chronic thromboembolic PH that are the main pulmonary vascular diseases and hereafter summarized as PH.
The leading symptom in PH is dyspnoea on exertion, impaired exercise performance, daily activity and quality of life.With progression of the disease, worsening hemodynamics may lead to gas exchange disturbances associated with hypoxemia, particularly during exercise and sleep. For a long time, the occurrence of PH was associated with a dismal prognosis progressively leading to right heart failure and death within months to a few years. Although PH is still incurable, recent therapeutic advances including medical or interventional therapies have improved the life expectancy, physical performance and quality of life of PH-patients and many patients seen in our daily practice wish to near-normally participate in professional work and recreational activities.
Globally, leisure time and professional activities at high altitude become increasingly popular exposing millions of people to hypobaric hypoxia annually. The alpine tourism in Europe and in other regions worldwide has a long lasting tradition and a relevant number of people have chosen their resident above 1500m above sea level.
Travel to high altitude and altitude-related adverse health effects (ARAHE):
Many Swiss villages and tourist resorts are located at altitudes between 1000 - 2500 m. In America, Asia and Africa, even large settlements are located at these or even higher altitudes and it is estimated that more than 50 million people permanently live above 2500 m. Accordingly, worldwide, millions of people travel regularly to mountain areas for business or recreation and expose themselves to hypobaric hypoxia during days to weeks or even longer. In addition, traveling by airplane, which has become extremely popular, further increased the number of people that are exposed to a hypoxic environment, as the minimally allowed cabin pressure in commercial air travel is equivalent to 2430 m (8000 ft) of altitude and this is often reached in intercontinental flights.
In healthy individuals, altitude exposure acutely induces hyperventilation by hypoxic chemoreceptor stimulation. This mitigates hypoxemia but promotes sleep disturbing high-altitude periodic breathing. About 50% of lowlanders ascending rapidly to >3000 m suffer from acute mountain sickness (AMS) causing headache, loss of appetite, weakness, fatigue and general discomfort. If AMS is not treated by descent, oxygen or medication, it may progress to life-threatening high altitude cerebral oedema. Furthermore, hypoxic pulmonary vasoconstriction (HPV) leads to an elevated PAP at altitude. In 2-4% of mountaineers climbing to 4559 m, excessive PAP-increase triggers high altitude pulmonary edema (HAPE), a non-cardiogenic pulmonary oedema associated with profound, potentially life-threatening hypoxemia, which is treated by oxygen therapy and may be prevented by phosphodiesterase type-5 inhibitor (PDE5i) administration or dexamethasone.
Contribution of this project to the gap in knowledge of the effects of hypoxia in PH:
The proposed trials will provide novel, robust data on the clinical and pathophysiological effects of exposure to a hypoxic environment in patients with PAH/CTEPH. This study will evaluate for the first time safety and tolerability of altitude exposure including an overnight stay in PH-patients and the effect of supplemental oxygen to reverse ARAHE. Close monitoring of patients including during exercise and sleep will provide insight into hypoxia-induced physiological mechanisms and the time course of altitude adaptation. Due to the special geographical location of Switzerland, we have the unique opportunity to study the response to hypobaric hypoxia in patients with PH in excellently suitable and safe settings in the nearby mountains and provide this important data to the scientific community worldwide for the benefit of many PH-patients and their advising caregivers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with: Stay at altitude 2500 m above sea level (high altitude) | Experimental | Procedure: Stay at altitude 2500 m above sea level (high altitude), Procedure: Stay at altitude 470 m above sea level (low altitude)Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m. |
| Start with: Stay at altitude 470 m above sea level (low altitude) | Placebo comparator | Procedure: Stay at altitude 2500 m above sea level (high altitude), Procedure: Stay at altitude 470 m above sea level (low altitude)Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m as comparator. |
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 |
|---|---|---|
| Stay at altitude 2500 m above sea level (high altitude)Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 2500 m. | Procedure or surgery | Start with: Stay at altitude 2500 m above sea level (high altitude), Start with: Stay at altitude 470 m above sea level (low altitude) |
| Stay at altitude 470 m above sea level (low altitude)Patients with precapillary pulmonary hypertension stay a sojourn of 30 h at 470 m. | Procedure or surgery | Start with: Stay at altitude 2500 m above sea level (high altitude), Start with: Stay at altitude 470 m above sea level (low altitude) |
Primary outcome
Incidence of altitude-related adverse health effects (ARAHE as defined below) during a sojourn at 2500m, time frame up to 30 h. ARAHE will be defined by any of the following criteria:
Time frame: 30 hours
* Acute mountain sickness with a Lake Louise score >4 including headache, or AMSc score ≥0.7 * severe hypoxemia defined as: resting SpO2 <75% for >15 min or <80% for >30 min; exercise SpO2 <75% for >5 min and/or criteria for stopping exercise according to guidelines * intercurrent illness: infection, neurologic, impairment, other new diseases/accidents, requiring medical treatment other than simple measures such as paracetamol * chest pain and/or ECG signs of cardiac ischemia, syncope, tachy- or bradyarrhythmia, severe hyper- or hypotension accompanied by symptoms * dyspnoea at rest and/or any discomfort requiring treatment and/or leading to the wish of a patient to return to low altitude or withdraw from the study
9 secondary outcomes
Components of altitude-related adverse health effects
Time frame: 30 hours
Severity of symptoms
Time frame: 30 hours
Difference in pulmonary artery pressure
Time frame: 30 hours
Difference in pulmonary vascular resistance assessed
Time frame: 30 hours
Difference in right ventricular function
Time frame: 30 hours
Resting electrocardiography
Time frame: 30 hours
Exercise electrocardiography
Time frame: 30 hours
Blood pressure
Time frame: 30 hours
Heart-rate variability
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 42398808Muller J, Schneider SR, Bauer M, Mayer L, Furian M, Lichtblau M, Ulrich S. The Effect of a 2-Day Stay at High Altitude (2,500 m) on Right Ventricular Afterload and Oxygen Delivery in Patients With Pulmonary Vascular Disease: A Randomized Controlled Crossover Trial. Chest. 2026 Jul 3:S0012-3692(26)00925-6. doi: 10.1016/j.chest.2026.06.032. Online ahead of print.
- Derived from this study: PubMed 40404280Muller J, Mayer L, Schneider SR, Bauer M, Furian M, Bloch KE, Schwarz EI, Lichtblau M, Silvia U. Pulmonary haemodynamics and right heart function during exercise at high versus low altitude in patients with pulmonary vascular disease: a randomised crossover trial. Heart. 2025 Dec 11;112(1):28-36. doi: 10.1136/heartjnl-2024-325605.
- 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 Stay at altitude 2500 m above sea level (high altitude) and Stay at altitude 470 m above sea level (low altitude) 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. Some participants in this study may receive a placebo. 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?
Incidence of altitude-related adverse health effects (ARAHE as defined below) during a sojourn at 2500m, time frame up to 30 h. ARAHE will be defined by any of the following criteria: (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 NCT05107700, which also lists 3 linked publications.
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.