Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)
1. november 2022 oppdatert av: University of Zurich
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH.
With this prospective cohort study the investigators intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.
Studietype
Observasjonsmessig
Registrering (Forventet)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Silvia Ulrich, MD
- Telefonnummer: ++41442552220
- E-post: pulmonalehypertonie@usz.ch
Studer Kontakt Backup
- Navn: Isabel Schmied
- Telefonnummer: ++41442552220
- E-post: pulmonalehypertonie@usz.ch
Studiesteder
-
-
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Zurich, Sveits, 8091
- Rekruttering
- University Hospital Zurich
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Ta kontakt med:
- Silvia Ulrich, PD MD
- Telefonnummer: 0041 44 255 22 20
- E-post: silvia.ulrich@usz.ch
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Hovedetterforsker:
- Silvia Ulrich, MD
-
-
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
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with precapillary pulmonary hypertension classified according to WHO
Beskrivelse
Inclusion Criteria:
- Patients with precapillary pulmonary hypertension
- Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
- Written informed consent by the subject after information about the research project
Exclusion Criteria:
- Patients with severe concomitant left heart disease (left ventricular ejection fraction <40%).
- Patients with restrictive lung disease (FVC<60% predicted); obstructive lung disease (forced expiratory volume (FEV) <60% predicted, with FEV 1/FVC<70%).
- Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
PH target therapy
Patients receiving PH target therapy
|
Patients receiving PH target therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Survival
Tidsramme: 10 years
|
Transplant free survival will be registered
|
10 years
|
|
Change in the 6 minute walk distance
Tidsramme: 10 years
|
The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
New York Heart association (NYHA) functional class
Tidsramme: 10 years
|
The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Score in health related Quality of Life (HRQoL) questionnaires
Tidsramme: 10 years
|
The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hemodynamic parameters by echocardiography
Tidsramme: 10 years
|
The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hospital days
Tidsramme: 10 years
|
Days spent in the hospital
|
10 years
|
|
red- and white blood cell counts
Tidsramme: 10 years
|
The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
Tidsramme: 10 years
|
The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)
|
10 years
|
|
Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
Tidsramme: 10 years
|
The change in utility will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Overnight sleep study parameters
Tidsramme: 10 years
|
The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Score in cognitive function tests
Tidsramme: 10 years
|
The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Cardiopulmonary exercise test parameters
Tidsramme: 10 years
|
The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
ECG parameters
Tidsramme: 10 years
|
The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Motion, step counts, metabolic equivalent
Tidsramme: 10 years
|
The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
|
10 years
|
|
Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
Tidsramme: 10 years
|
Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
|
10 years
|
|
Time, maximal power in stair-ascent test
Tidsramme: 10 years
|
Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Performance in Sit to stand test
Tidsramme: 10 years
|
Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
|
10 years
|
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Level of C-reactive protein (CRP)
Tidsramme: 10 years
|
The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)
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10 years
|
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Level of N-terminal brain natriuretic peptide (BNP)
Tidsramme: 10 years
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The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)
|
10 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Silvia Ulrich, MD, University Hospital Zurich, Department of Pulmonology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. september 2014
Primær fullføring (Forventet)
1. september 2024
Studiet fullført (Forventet)
1. september 2024
Datoer for studieregistrering
Først innsendt
16. september 2014
Først innsendt som oppfylte QC-kriteriene
25. september 2014
Først lagt ut (Anslag)
26. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. november 2022
Sist bekreftet
1. november 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014-0214_ZH PH Cohort
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