Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)
1 november 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
100
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Silvia Ulrich, MD
- Telefonnummer: ++41442552220
- E-post: pulmonalehypertonie@usz.ch
Studera Kontakt Backup
- Namn: Isabel Schmied
- Telefonnummer: ++41442552220
- E-post: pulmonalehypertonie@usz.ch
Studieorter
-
-
-
Zurich, Schweiz, 8091
- Rekrytering
- University Hospital Zurich
-
Kontakt:
- Silvia Ulrich, PD MD
- Telefonnummer: 0041 44 255 22 20
- E-post: silvia.ulrich@usz.ch
-
Huvudutredare:
- Silvia Ulrich, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with precapillary pulmonary hypertension classified according to WHO
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
PH target therapy
Patients receiving PH target therapy
|
Patients receiving PH target therapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Survival
Tidsram: 10 years
|
Transplant free survival will be registered
|
10 years
|
|
Change in the 6 minute walk distance
Tidsram: 10 years
|
The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
New York Heart association (NYHA) functional class
Tidsram: 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
Tidsram: 10 years
|
The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hemodynamic parameters by echocardiography
Tidsram: 10 years
|
The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hospital days
Tidsram: 10 years
|
Days spent in the hospital
|
10 years
|
|
red- and white blood cell counts
Tidsram: 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
Tidsram: 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
Tidsram: 10 years
|
The change in utility will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Overnight sleep study parameters
Tidsram: 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
Tidsram: 10 years
|
The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Cardiopulmonary exercise test parameters
Tidsram: 10 years
|
The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
ECG parameters
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 10 years
|
Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Level of C-reactive protein (CRP)
Tidsram: 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)
|
10 years
|
|
Level of N-terminal brain natriuretic peptide (BNP)
Tidsram: 10 years
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Silvia Ulrich, MD, University Hospital Zurich, Department of Pulmonology
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2014
Primärt slutförande (Förväntat)
1 september 2024
Avslutad studie (Förväntat)
1 september 2024
Studieregistreringsdatum
Först inskickad
16 september 2014
Först inskickad som uppfyllde QC-kriterierna
25 september 2014
Första postat (Uppskatta)
26 september 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 november 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 november 2022
Senast verifierad
1 november 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014-0214_ZH PH Cohort
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .