Evaluation of Fontan-Associated Liver Disease (FALD)
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|ClinicalTrials.gov Identifier: NCT03430583|
Recruitment Status : Unknown
Verified November 2020 by Mezzion Pharma Co. Ltd.
Recruitment status was: Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : November 24, 2020
|Condition or disease||Intervention/treatment|
|Single Ventricle Heart Disease||Drug: MZ101|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Dosing per treatment regimen
- Range of Liver Stiffness in Adolescents with Single Ventricle Heart Disease [ Time Frame: 12 months ]Liver Stiffness as measured by Shear Wave Ultrasound Elastography (meters/second) or Magnetic Resonance Ultrasound (kilopascals).
- Effect of Drug Therapy on Liver Stiffness [ Time Frame: 12 months ]Liver Stiffness as measured by Shear Wave Ultrasound Elastography (meters/second) or Magnetic Resonance Ultrasound (kilopascals).
- Effect of Drug Therapy on Brain Type Natriuretic Peptide (BNP) Levels [ Time Frame: 12 months ]Measurement of plasma levels of BNP
- Effect of Drug Therapy on n-Terminal BNP (NT-proBNP) [ Time Frame: 12 months ]Measurement of plasma levels of NT-proBNP
- Effect of Drug Therapy on MicroRNA Measures. [ Time Frame: 12 months ]Measurement of MicroRNA by miRNA qRT-PCR analysis of total RNA from plasma
- Effect of Drug Therapy on Enhanced Liver Fibrosis (ELF) Score [ Time Frame: 12 months ]Measurement of ELF Score
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430583
|Principal Investigator:||David J Goldberg, MD||Children's Hospital of Philadelphia|
|Principal Investigator:||Kurt R Schumacher, MD||University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital|