Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
2026. augusztus 31. frissítette: Silvia Ulrich Somaini
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 a re-ascent to high altitude (Quito Ecuador: 2850m) after a one-week stay at sea level (after prior descent from 2850m) on lung function and pulmonary resistance/reactance in patients with pulmonary arterial disease PAH, who live permanently > 2600m.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
The aim of this research is to investigate the lung function and pulmonary resistance/reactance before and after re-ascent (sea level for 7 days after prior descent from 2850m vs. re-ascent to 2850m) in patients with diagnosed pulmonary hypertension according to guidelines, who permanently live at high altitude over 2600m.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
20
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Silvia Ulrich, Prof. Dr. med.
- Telefonszám: +41442552220
- E-mail: silvia.ulrich@usz.ch
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Michael Furian, Prof. Dr. sc. ETH
- Telefonszám: +41442552220
Tanulmányi helyek
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Zurich, Svájc, 8091
- University Hospital of Zurich
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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)
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Lung function at sea level and at 2850m
Assessment of lung function and pulmonary resistance/reactance on day four at sea level (after prior descent from 2850m) and after re-ascent (after totally one week at sea level) back to 2850m by bus (in one day)
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Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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FEV1 after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in forced expiratory volume in one second FEV1 between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in forced vital capacity FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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FEV1/FVC after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in FEV1/FVC between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in respiratory impedance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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Difference/change in respiratory resistance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Időkeret: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Difference/change in respiratory reactance (forced oscillation technique) between sea level (measurement on the 4th day) and day after re-ascent to 2850m in patients with pulmonary arterial hypertension
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From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
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FEV1 after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Forced Vital Capacity FVC after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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FEV1/FVC after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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Difference/change in respiratory impedance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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Respiratory resistance (forced oscillation technique) after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory resistance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory reactance (forced oscillation technique) after 4 days at sea level
Időkeret: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in respiratory reactance (forced oscillation technique) between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
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From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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FEV1 pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
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Difference/change in FEV1 at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial disease
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Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
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Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in forced vital capacity FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
FEV1/FVC pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in FEV1/FVC at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory Impedance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory impedance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory resistance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory resistance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
|
Respiratory reactance (forced oscillation technique) pre-descent and after re-ascent (2850m)
Időkeret: Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Difference/change in respiratory reactance (forced oscillation technique) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in patients with pulmonary arterial hypertension
|
Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days)
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Kutatásvezető: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. szeptember 25.
Elsődleges befejezés (Becsült)
2026. október 4.
A tanulmány befejezése (Becsült)
2026. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. augusztus 17.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 31.
Első közzététel (Tényleges)
2026. szeptember 4.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 4.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 31.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- Ec_LAvsHA_Lufu_PAH
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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