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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 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Silvia Ulrich, Prof. Dr. med.
  • Numéro de téléphone: +41442552220
  • E-mail: silvia.ulrich@usz.ch

Sauvegarde des contacts de l'étude

  • Nom: Michael Furian, Prof. Dr. sc. ETH
  • Numéro de téléphone: +41442552220

Lieux d'étude

  • Suisse
      • Zurich, Suisse, 8091
        • University Hospital of Zurich

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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)
Comportemental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
FEV1 after re-ascent to 2850m
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Forced Vital Capacity FVC after re-ascent to 2850m
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Silvia Ulrich Somaini

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

25 septembre 2026

Achèvement primaire (Estimé)

4 octobre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

17 août 2026

Première soumission répondant aux critères de contrôle qualité

31 août 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Ec_LAvsHA_Lufu_PAH

Plan pour les données individuelles des participants (IPD)

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Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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