Pulmonary Vascular DiseaseNCT06092424
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
A study testing Relocation from HA to LA in people with Pulmonary Vascular Disease and Pulmonary Arterial Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Relocation from HA to LA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2023to 31 Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18-90 years old of both genders,
- Residence > 2500m of altitude
- diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- New York Heart Association (NYHA) functional class I-III
- Provided written informed consent to participate in the study.
Who cannot join
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations, patient permanently living < 2500m.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulse-oximetry (SpO2) <80% on ambient air.
- Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)
- Patient with a non-corrected ventricular septum defect
- Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics.
Read the detailed description
This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.
- Conditions
- Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- Relocation from HA to LA
- Keywords
- pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relocation from HA to LABehavioural
Patients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes
| Study group | Role | What they receive |
|---|---|---|
| Investigations at High altitude (HA, 2840m) | Active comparator | PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m Receives: Behavioral: Relocation from HA to LA |
| Investigations at Low altitude (LA, sea level) | Experimental | PAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level) Receives: Behavioral: Relocation from HA to LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)
Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)
Measured: in the morning of the second day at sea level
Secondary outcomes (9)
Cardiac output in the morning of the second day at sea level
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840 m)
Measured: in the morning of the second day at sea level
Cardiac output in the morning of the third day at sea level
Change in cardiac output in l/min assessed by echocardiography between LA (sea level) vs HA (2840m)
Measured: in the morning of the third day at sea level
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level
Tricuspid pressure gradient assessed by echocardiography between LA (sea level) vs HA (2840m)
Measured: in the morning of the second day at sea level
Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level
Tricuspid pressure gradient assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Measured: in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level
Tricupsid annular plane systolic excursion assessed by echocardiography assessed by between LA (sea level) vs HA (2840m)
Measured: in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography assessed by between LA (sea level) vs HA (2840m)
Measured: in the morning of the third day at sea level
ph by arterial blood gases in the morning of the second day at sea level
Change in ph by arterial blood gases assessed between LA (sea level) vs HA (2840m)
Measured: in the morning of the second day at sea level
partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level
Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (sea level) vs HA (2840m)
Measured: in the morning of the second day at sea level
partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level
Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (sea level) vs HA (2840m)
Measured: in the morning of the second day at sea level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Sep 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Vascular DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092424
- Sponsor's protocol ID
- PVD_HAvsLA_PAP
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to the PI and after publication of results, data will be shared upon reasonable research questions and ethical approval
Publications
Ulrich S, Muller J, Furian M, Saxer S, Schneider SR, Herzig J, Bauer M, Schmucki M, Saragoni D, Mayer L, Schwarz EI, Cajamarca E, Hoyos R, Lichtblau M. Effects of a Sea-Level Stay on Pulmonary Hemodynamics in Patients With Pulmonary Arterial Hypertension Living in Quito Near 2,850 m. Chest. 2026 Mar 30:S0012-3692(26)00423-X. doi: 10.1016/j.chest.2026.02.043. Online ahead of print.
PubMed 41921908
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Pulmonary Artery Pressure (PAP) and Other Hemodynamics Assessed by Echocardiography in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level
- ClinicalTrials.gov ID
- NCT06092424
- Acronym / sponsor ID
- PVD_HAvsLA_PAP
- Conditions
- Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Keywords
- pulmonary hypertension, Pulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension, high altitude, hypoxia, pulmonary artery pressure, arterial blood gases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on pulmonary artery pressure (PAP) and other hemodynamics.
Detailed description
This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be investigated at high altitude (HA, 2840m) and low altitude (LA, sea level)
| Arm | Type | Receives |
|---|---|---|
| Investigations at High altitude (HA, 2840m) | Active comparator | Behavioral: Relocation from HA to LAPAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m |
| Investigations at Low altitude (LA, sea level) | Experimental | Behavioral: Relocation from HA to LAPAP and other hemodynamics assessed by echocardiography and blood gases after the first and second night at LA (sea level) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients 18-90 years old of both genders,
- Residence > 2500m of altitude
- diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- New York Heart Association (NYHA) functional class I-III
Key exclusion criteria (8 listed)
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations, patient permanently living < 2500m.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
- Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulse-oximetry (SpO2) <80% on ambient air.
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 |
|---|---|---|
| Relocation from HA to LAPatients will be relocated by bus from Quito (2840m) to Pedernales (sea level) and have investigations at both altitudes | Behavioural | Investigations at High altitude (HA, 2840m), Investigations at Low altitude (LA, sea level) |
Primary outcome
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA)
Time frame: in the morning of the second day at sea level
Change in PAP in mmHg assessed by echocardiography between LA (sea level) vs High altitude (HA)
9 secondary outcomes
Cardiac output in the morning of the second day at sea level
Time frame: in the morning of the second day at sea level
Cardiac output in the morning of the third day at sea level
Time frame: in the morning of the third day at sea level
Tricuspid pressure gradient by echocardiography in the morning of the second day at sea level
Time frame: in the morning of the second day at sea level
Tricuspid pressure gradient by echocardiography in the morning of the third day at sea level
Time frame: in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography in the morning of the second day at sea level
Time frame: in the morning of the third day at sea level
Tricupsid annular plane systolic excursion by echocardiography in the morning of the third day at sea level
Time frame: in the morning of the third day at sea level
ph by arterial blood gases in the morning of the second day at sea level
Time frame: in the morning of the second day at sea level
partial pressure of oxygen (PaO2) by arterial blood gases in the morning of the second day at sea level
Time frame: in the morning of the second day at sea level
partial pressure of carbon dioxide (PaCO2) by arterial blood gases in the morning of the second day at sea level
Time frame: in the morning of the second day at sea level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41921908Ulrich S, Muller J, Furian M, Saxer S, Schneider SR, Herzig J, Bauer M, Schmucki M, Saragoni D, Mayer L, Schwarz EI, Cajamarca E, Hoyos R, Lichtblau M. Effects of a Sea-Level Stay on Pulmonary Hemodynamics in Patients With Pulmonary Arterial Hypertension Living in Quito Near 2,850 m. Chest. 2026 Mar 30:S0012-3692(26)00423-X. doi: 10.1016/j.chest.2026.02.043. Online ahead of print.
- Individual participant dataSharing planned: Yes. Upon request to the PI and after publication of results, data will be shared upon reasonable research questions and ethical approval
Related trials for Pulmonary Vascular Disease
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 Relocation from HA to LA in people with Pulmonary Vascular Disease and Pulmonary Arterial 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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?
Results are not available in the source record.
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?
Pulmonary artery Pressure (PAP) in the morning of second day at sea level (LA) (time frame: in the morning of the second day at sea level). 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 NCT06092424, which also lists 1 linked publication.
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 23 Oct 2023.