Pulmonary Vascular DiseaseNCT06072417
HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)
A study testing Assessment without intervention at High altitude and Relocation to sea level for 2 days in people with Pulmonary Vascular Disease and Pulmonary Artery 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 sleep disordered breathing Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Assessment without intervention at High altitude and Relocation to sea level for 2 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Sep 2023to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18-80 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- NYHA (new york heart association) 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 SpO2 (oxygen saturation by pulseoximetry) <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.
About this study
Official title: Comparative Study of Sleep Disordered Breathing (SDB) 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 sleep disordered breathing
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 (PVDHA) will have nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during the first and the second night after relocation.
- Conditions
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- Assessment without intervention at High altitude, Relocation to sea level for 2 days
- Keywords
- Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Hypertension, Pulmonary, Hypoxia, Sleep Apnea Syndromes, Pulmonary Arterial Hypertension, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment without intervention at High altitudeOther
Assessments at High altitude corresponding to Baseline measures
Relocation to sea level for 2 daysOther
Participants will be relocated to sea level and intervention and have assessements there.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory sleep study at 2840m | Placebo comparator | Participants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m Receives: Other: Assessment without intervention at High altitude |
| Respiratory sleep study near sea level (0-30m) | Experimental | Participants will have a respiratory sleep study by polygraphy near sea level (0-30m) Receives: Other: Relocation to sea level for 2 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean nocturnal SpO2 at LA vs. HA
Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)
Measured: during the first night at low altitude (of intervention)
Secondary outcomes (8)
Mean nocturnal SpO2 at LA vs. HA
Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)
Measured: during the second night at low altitude (of intervention)
Time spent with SpO2<90% at LA vs. HA
Change in time spent with SpO2<90% between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude (of intervention)
AHI at LA vs. HA
Change in apnea-hypopnea index (AHI) between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude (of intervention)
ODI at LA vs. HA
Change in oxygen desaturation index (ODI) between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude (of intervention)
Time spent with periodic breathing at LA vs. HA
Change in time spent with periodic breathingbetween LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude (of intervention)
Heart rate variability at LA vs. HA
Change in heart rate variability between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude (of intervention)
ECG markers of repolarization at LA vs. HA
Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude
pulse transit time drops at LA vs. HA
Change in pulse transit time drops between LA (sea level) vs HA (2840 m)
Measured: during the first and second night at low altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start22 Sep 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 living permanently \>2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea level
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof. Dr., Principal investigator, University Hospital Zurich, Departement of PulmonologyRodrigo Hoyos, Dr., Principal investigator, Carlos Adrade Marin Hospital of Quito, Equador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072417
- Sponsor's protocol ID
- PVD_HAvsLA_SDB
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sleep Disordered Breathing (SDB) 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
- NCT06072417
- Acronym / sponsor ID
- PVD_HAvsLA_SDB
- Conditions
- Pulmonary Vascular Disease, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Hypoxia, sleep disordered breathing, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 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 sleep disordered breathing
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 (PVDHA) will have nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during 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 living permanently >2500m around Quito (Equador) will be assessed at 2840m and after relocation to sea level
| Arm | Type | Receives |
|---|---|---|
| Respiratory sleep study at 2840m | Placebo comparator | Other: Assessment without intervention at High altitudeParticipants will have a respiratory sleep study by polygraphy near their resident altitude at 2840m |
| Respiratory sleep study near sea level (0-30m) | Experimental | Other: Relocation to sea level for 2 daysParticipants will have a respiratory sleep study by polygraphy near sea level (0-30m) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients 18-80 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 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- Patients stable on therapy
- NYHA (new york heart association) 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 SpO2 (oxygen saturation by pulseoximetry) <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 |
|---|---|---|
| Assessment without intervention at High altitudeAssessments at High altitude corresponding to Baseline measures | Other | Respiratory sleep study at 2840m |
| Relocation to sea level for 2 daysParticipants will be relocated to sea level and intervention and have assessements there. | Other | Respiratory sleep study near sea level (0-30m) |
Primary outcome
Mean nocturnal SpO2 at LA vs. HA
Time frame: during the first night at low altitude (of intervention)
Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)
8 secondary outcomes
Mean nocturnal SpO2 at LA vs. HA
Time frame: during the second night at low altitude (of intervention)
Time spent with SpO2<90% at LA vs. HA
Time frame: during the first and second night at low altitude (of intervention)
AHI at LA vs. HA
Time frame: during the first and second night at low altitude (of intervention)
ODI at LA vs. HA
Time frame: during the first and second night at low altitude (of intervention)
Time spent with periodic breathing at LA vs. HA
Time frame: during the first and second night at low altitude (of intervention)
Heart rate variability at LA vs. HA
Time frame: during the first and second night at low altitude (of intervention)
ECG markers of repolarization at LA vs. HA
Time frame: during the first and second night at low altitude
pulse transit time drops at LA vs. HA
Time frame: during the first and second night at low altitude
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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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. Dr. principal investigator
University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos, Dr. principal investigator
Carlos Adrade Marin Hospital of Quito, Equador
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 without intervention at High altitude and Relocation to sea level for 2 days in people with Pulmonary Vascular Disease and Pulmonary Artery 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 10 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. 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?
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?
Mean nocturnal SpO2 at LA vs. HA (time frame: during the first night at low altitude (of intervention)). 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 10 Oct 2023.