High Altitude EffectsNCT07801859
Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Patients With Pulmonary Arterial Hypertension PAH
A study testing Descent and re-ascent (2850m, sea level) in people with High Altitude Effects and High Altitude, run by Silvia Ulrich Somaini at 1 site in Switzerland.
Trial summary
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in patients with pulmonary arterial hypertension PAH, who live permanently >2600m. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High Altitude Effects, High Altitude, Pulmonary Vascular Disease
- What is being tested?
- Descent and re-ascent (2850m, sea level)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 18-80 years and of all genders
- Permanent residence > 2600 m
- Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
- Patients are stable on therapy
- NYHA (new york heart association) functional class I-III.
- 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 < 2600m.
- Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 cigarettes/day)
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- Severely hypoxemic patients at Quito permanently having persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
- 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. Contact the study team or a site near you to ask about taking part.
Michael Furian, Prof. Dr. sc. ETH contact
About this study
Official title: Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
Read the detailed description
The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m
- Conditions
- High Altitude Effects, High Altitude, Pulmonary Vascular Disease, Pulmonary Arterial Hypertension (PAH), Heart Rate Variability (HRV), ECG Abnormalities
- Being tested
- Descent and re-ascent (2850m, sea level)
- Keywords
- Pulmonary hypertension, Pulmonary arterial hypertension PAH, Pulmonary vascular disease, High altitude, Heart rate variability, ECG, Arrythmias, Pulse transit time
- Medical subject headings
- Altitude Sickness, Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descent and re-ascent (2850m, sea level)Behavioural
Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)
| Study group | Role | What they receive |
|---|---|---|
| Heart rate variability HRV during descent and re-ascent | Experimental | Assessment of heart rate variability and other hemodynamic outcomes in patients with pulmonary arterial disease during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back near their living altitude at 2850m Receives: Behavioral: Descent and re-ascent (2850m, sea level) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability HRV during descent and re-ascent
Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
Measured: From day of descent (day 1) and day of re-ascent (day 8)
Secondary outcomes (4)
SpO2 during descent and re-ascent
Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
Measured: From day of descent (day 1) and day of re-ascent (day 8)
ECG-Repolarization during descent and re-ascent
Difference/change in ECG-repolarization at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
Measured: From day of descent (day 1) and day of re-ascent (day 8)
Cardial arrhythmias during descent and re-ascent
Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
Measured: From day of descent (day 1) and day of re-ascent (day 8)
Pulse transit time during descent and re-ascent
Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
Measured: From day of descent (day 1) and day of re-ascent (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion4 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude EffectsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with pulmonary arterial hypertension living permanently \> 2600m around Quito (Ecuador) will be assessed during descent from 2850m to sea level and during re-ascent after one week from sea level to 2850m
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silvia Ulrich Somaini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvia Ulrich Somaini, University of Zurich
- Investigators
- Silvia Ulrich, Principal investigator, University Hospital Zurich, Departement of PulmonologyRodrigo Hoyos, Principal investigator, Hospital Carlos Andrade Marin of Quito, Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801859
- Sponsor's protocol ID
- Ec_DEvsA_HRV_PAH
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes
- ClinicalTrials.gov ID
- NCT07801859
- Acronym / sponsor ID
- Ec_DEvsA_HRV_PAH
- Conditions
- High Altitude Effects, High Altitude, Pulmonary Vascular Disease, Pulmonary Arterial Hypertension (PAH), Heart Rate Variability (HRV), ECG Abnormalities
- Keywords
- Pulmonary hypertension, Pulmonary arterial hypertension PAH, Pulmonary vascular disease, High altitude, Heart rate variability, ECG, Arrythmias, Pulse transit time
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Silvia Ulrich SomainiUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 4 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2026 (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 high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
Detailed description
The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with pulmonary arterial hypertension living permanently > 2600m around Quito (Ecuador) will be assessed during descent from 2850m to sea level and during re-ascent after one week from sea level to 2850m
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability HRV during descent and re-ascent | Experimental | Behavioral: Descent and re-ascent (2850m, sea level)Assessment of heart rate variability and other hemodynamic outcomes in patients with pulmonary arterial disease during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back near their living altitude at 2850m |
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 aged 18-80 years and of all genders
- Permanent residence > 2600 m
- Diagnosis of pulmonary arterial hypertension PAH (PAHHA-Group) according to guidelines
- Patients are stable on therapy
- NYHA (new york heart association) functional class I-III.
Key exclusion criteria (9 listed)
- Age <18 years or >80 years
- unstable condition
- Patients who cannot follow the study investigations
- Patient permanently living < 2600m.
- Patients who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
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 |
|---|---|---|
| Descent and re-ascent (2850m, sea level)Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus) | Behavioural | Heart rate variability HRV during descent and re-ascent |
Primary outcome
Heart rate variability HRV during descent and re-ascent
Time frame: From day of descent (day 1) and day of re-ascent (day 8)
Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
4 secondary outcomes
SpO2 during descent and re-ascent
Time frame: From day of descent (day 1) and day of re-ascent (day 8)
ECG-Repolarization during descent and re-ascent
Time frame: From day of descent (day 1) and day of re-ascent (day 8)
Cardial arrhythmias during descent and re-ascent
Time frame: From day of descent (day 1) and day of re-ascent (day 8)
Pulse transit time during descent and re-ascent
Time frame: From day of descent (day 1) and day of re-ascent (day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
Michael Furian, Prof. Dr. sc. ETH contact
Silvia Ulrich principal investigator
University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos principal investigator
Hospital Carlos Andrade Marin of Quito, Ecuador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descent and re-ascent (2850m, sea level) in people with High Altitude Effects and High Altitude, run by Silvia Ulrich Somaini 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 9 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Ulrich, Prof. Dr. med. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability HRV during descent and re-ascent (time frame: From day of descent (day 1) and day of re-ascent (day 8)). 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 3 Sep 2026.