- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03726229
Cholate Clearance in Fontans
Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.
The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.
Studieöversikt
Detaljerad beskrivning
A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.
The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Hospital of the University of Pennsylvania
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- s/p Fontan operation
- cardiac catheterization or cardiac MRI within 1 year of enrollment
Exclusion Criteria:
- pregnant or breastfeeding
- unable to comprehend and/or give informed consent
- sensitivity to human serum albumin, or its preparations
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Fontan patient
Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance.
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Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hepatic cholate clearance
Tidsram: Through study completion, an average of 1 year
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D4-cholate and 13C-cholate clearance
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Through study completion, an average of 1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of adverse clinical outcomes
Tidsram: 5 years after cholate assay
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combined outcome of occurrence of any of the following: heart failure admission, clinically significant ascites, protein losing enteropathy, referral for cardiac transplantation, death
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5 years after cholate assay
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yuli Kim, MD, University of Pennsylvania
- Huvudutredare: Maarouf Hoteit, MD, Hospital of the University of Pennslyvania
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 829578
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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Kliniska prövningar på Fontan-förfarande
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Children's Hospital Medical Center, CincinnatiAvslutad
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Children's Hospital Medical Center, CincinnatiAmerican Heart AssociationAvslutad
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St. Boniface HospitalHar inte rekryterat ännu
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Stanford UniversityAvslutadFontan fysiologiFörenta staterna
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Milton S. Hershey Medical CenterChildren's Miracle NetworkAvslutadFontan CirculationFörenta staterna
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University of MichiganAvslutad
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University of MichiganAvslutadFontan PalliationFörenta staterna
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Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)RekryteringFontan PalliationFörenta staterna
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University of MichiganAvslutadFontan-förfarandeFörenta staterna
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University Health Network, TorontoHayek MedicalAvslutad
Kliniska prövningar på Cholate assay
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Northwestern UniversityUniversity of Colorado, DenverAvslutadKardiovaskulär sjukdom | Leversjukdom
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Abbott Diagnostics DivisionAvslutad
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Prof.dr. H.P. BeerlageRadboud University Medical Center; Amsterdam UMC, location VUmc; The Netherlands... och andra samarbetspartnersRekrytering
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University Health Network, TorontoPrincess Margaret Hospital, Canada; The Princess Margaret Cancer FoundationAvslutadLungcancer Stadium IVKanada
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BioMérieuxBioFortis; APHPOkändLuftvägsinfektionerFrankrike
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Gen-Probe, IncorporatedAvslutad
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Rijnstate HospitalHar inte rekryterat ännuArtroplastik, Ersättning, Knä | Protesrelaterade infektioner | Artroplastik, Ersättning, Höft
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Becton, Dickinson and CompanyAktiv, inte rekryterande
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Seattle Institute for Biomedical and Clinical ResearchGenomind, LLCAktiv, inte rekryterandeFarmakogenetisk testningFörenta staterna
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Biruni UniversityHar inte rekryterat ännuReumatoid artrit | Parodontit