Assessment of Heart Rate Variability HRV During Descent DE From 2850m to Sea Level and During Re-ascent A From Sea Level to 2850m in Patients With Pulmonary Arterial Hypertension PAH
31. august 2026 oppdatert 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 relocation from high altitude (Quito Ecuador: 2850m) to sea level and re-ascent from sea level to 2850m on heart rate variability and other hemodynamic parameters in patients with pulmonary arterial hypertension PAH, who live permanently >2600m.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim of this research is to investigate the heart rate variability and other hemodynamic outcomes during the descent from 2850m to sea level and during re-ascent from sea level to 2850m in patients with diagnosed pulmonary arterial hypertension according to guidelines, who permanently live at high altitude over 2600m
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Silvia Ulrich, Prof. Dr. med.
- Telefonnummer: +41442552220
- E-post: silvia.ulrich@usz.ch
Studer Kontakt Backup
- Navn: Michael Furian, Prof. Dr. sc. ETH
- Telefonnummer: +41442552220
Studiesteder
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-
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Zurich, Sveits, 8091
- University Hospital of Zurich
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Heart rate variability HRV during descent and re-ascent
Assessment of heart rate variability and other hemodynamic outcomes in patients with pulmonary arterial disease during descent from 2850m to sea level and during re-ascent from sea level (after one week stay) back near their living altitude at 2850m
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Descent from 2850m to sea level (in one day by bus) and re-ascent after 7 days from sea level to 2850m (in one day by bus)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart rate variability HRV during descent and re-ascent
Tidsramme: From day of descent (day 1) and day of re-ascent (day 8)
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Difference/change in heart rate variability at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
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From day of descent (day 1) and day of re-ascent (day 8)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SpO2 during descent and re-ascent
Tidsramme: From day of descent (day 1) and day of re-ascent (day 8)
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Difference/change in SpO2 at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
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From day of descent (day 1) and day of re-ascent (day 8)
|
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ECG-Repolarization during descent and re-ascent
Tidsramme: From day of descent (day 1) and day of re-ascent (day 8)
|
Difference/change in ECG-repolarization at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
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From day of descent (day 1) and day of re-ascent (day 8)
|
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Cardial arrhythmias during descent and re-ascent
Tidsramme: From day of descent (day 1) and day of re-ascent (day 8)
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Occurrence/changes in cardial arrhythmias at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
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From day of descent (day 1) and day of re-ascent (day 8)
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Pulse transit time during descent and re-ascent
Tidsramme: From day of descent (day 1) and day of re-ascent (day 8)
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Occurrence and difference/change in pulse transit time (drops) at different altitudes during descent (2850m to sea level) and during re-ascent after 7 days (sea level to 2850m) in patients with pulmonary arterial hypertension
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From day of descent (day 1) and day of re-ascent (day 8)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Hovedetterforsker: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. september 2026
Primær fullføring (Antatt)
4. oktober 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
17. august 2026
Først innsendt som oppfylte QC-kriteriene
31. august 2026
Først lagt ut (Faktiske)
3. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ec_DEvsA_HRV_PAH
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
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