Assessment of Lung Function (Lufu) at Sea Level LA vs. High Altitude HA in Patients With Pulmonary Arterial Hypertension PAH
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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Silvia Ulrich, Prof. Dr. med.
- Puhelinnumero: +41442552220
- Sähköposti: silvia.ulrich@usz.ch
Tutki yhteystietojen varmuuskopiointi
- Nimi: Michael Furian, Prof. Dr. sc. ETH
- Puhelinnumero: +41442552220
Opiskelupaikat
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Zurich, Sveitsi, 8091
- University Hospital of Zurich
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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FEV1 after re-ascent to 2850m
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Forced Vital Capacity FVC after re-ascent to 2850m
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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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
Aikaikkuna: 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 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: From high altitude (Day 0, 2850m) to day 4 at sea level (approximately 5 days)
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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)
|
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Respiratory reactance (forced oscillation technique) after 4 days at sea level
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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 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
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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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FEV1/FVC pre-descent and after re-ascent (2850m)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Päätutkija: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
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