Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
31 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Silvia Ulrich, Prof. Dr. med.
- Telefonnummer: +41442552220
- E-post: silvia.ulrich@usz.ch
Studera Kontakt Backup
- Namn: Michael Furian, Prof. Dr. sc. ETH
- Telefonnummer: +41442552220
Studieorter
-
-
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Zurich, Schweiz, 8091
- University Hospital of Zurich
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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)
|
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FEV1 after re-ascent to 2850m
Tidsram: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Forced Vital Capacity FVC after re-ascent to 2850m
Tidsram: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
FEV1/FVC after re-ascent to 2850m
Tidsram: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory Impedance (forced oscillation technique) after re-ascent to 2850m
Tidsram: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory resistance (forced oscillation technique) after re-ascent to 2850m
Tidsram: From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
Respiratory reactance (forced oscillation technique) after re-ascent to 2850m
Tidsram: 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
|
From Day 4 at sea level to the day after re-ascent (Day 9: approximately 6 days)
|
|
FEV1 after 4 days at sea level
Tidsram: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in FEV1 between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Forced Vital Capacity FVC after 4 days at sea level
Tidsram: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in forced vital capacity FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
FEV1/FVC after 4 days at sea level
Tidsram: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
Difference/change in FEV1/FVC between 2850m (prior to descent) and day 4 at sea level in patients with pulmonary arterial disease
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory Impedance (forced oscillation technique) after 4 days at sea level
Tidsram: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
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
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
Respiratory resistance (forced oscillation technique) after 4 days at sea level
Tidsram: 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
|
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
Tidsram: 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
|
From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
|
|
FEV1 pre-descent and after re-ascent (2850m)
Tidsram: 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 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
|
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)
|
|
Forced Vital Capacity FVC pre-descent and after re-ascent (2850m)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Huvudutredare: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
25 september 2026
Primärt slutförande (Beräknad)
4 oktober 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
17 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
31 augusti 2026
Första postat (Faktisk)
4 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Ec_LAvsHA_Lufu_PAH
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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