- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02541981
Natural Course for Renal Function After Heart Transplantation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The investigators conducted a retrospective cohort study of patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 . Clinical data were obtained and a retrospective chart review, and were collected up to 10 years .
Data was collected from medical records and the heart transplant electronic database including: demographic parameters such as age and gender; etiology of heart failure; the presence of any of the following comorbidities: history of smoking, diabetes, hypertension, peripheral vascular disease and previous sternotomy; pre-transplant cholesterol levels; the use of any of the following pretransplant hemodynamic support measures:intravenous inotropes, intra-aortic balloon pump and ventricular assist device;creatinine levels; listing status according to the UNOS classification; waiting time; heart ischemic time;immunosuppression drug levels(cyclosporine,prograft or certican) and development of end stage renal disease requiring onset of dialysis therapy.
Creatinine levels and GFRwere collected before transplantation and then the closest level to every month after heart transplant.
The clinical outcomes of interest analyzed in this study included the development of post-transplant end stage renal disease and death.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan
- National Taiwan University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
This study included patients with a first HTx performed at NTUH between1987 and 2015.
Patients were excluded if their first HTx was a combined transplant involving a KTx, they had renal replacement therapy prior to their HTx.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Natural course for renal function (ex blood creatine leveal ,eGFR) after heart transplantation
Tidsramme: patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015
|
the outcome measure is assessed up to 10 years
|
patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Chen Cheryl Chia-Hui, PHD, Professor , School of Nursing, National Taiwan University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 201507087RIND
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