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Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH

31 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Michael Furian, Prof. Dr. sc. ETH
  • Telefoonnummer: +41442552220

Studie Locaties

  • Zwitserland
      • Zurich, Zwitserland, 8091
        • University Hospital of Zurich

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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)
Gedragsmatig: Re-ascent from sea level to 2850m
Descent from 2850m to sea level with a stay for 7 days and re-ascent/return back to their usual living altitude at 2850m

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FEV1 after re-ascent to 2850m
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Forced Vital Capacity FVC after re-ascent to 2850m
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Silvia Ulrich Somaini

Onderzoekers

  • Hoofdonderzoeker: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
  • Hoofdonderzoeker: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

25 september 2026

Primaire voltooiing (Geschat)

4 oktober 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 augustus 2026

Eerst geplaatst (Werkelijk)

4 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

31 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Ec_LAvsHA_Lufu_PAH

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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