An observational study in Single-ventricle and Hepatic Congestion, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Boston Children's Hospital · Observational
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to obtain liver stiffness measurements (LSM) before and after fenestration closure to study the impact of this intervention on hepatic congestion.
Methods Eligible patients will be contacted in advance of hospitalization for catheterized fenestration closure to introduce goals of study and review risks and benefits of participation. At the time of catheterization, the study objectives and consent forms will be explained, allowing sufficient time for questions. To ensure full comprehension of the study, the parent or guardian will be asked to describe his or her participation in the trial.
Using the Fibroscan (Echosens, Paris, France), a transient elastography device, a liver stiffness measurement (LSM) will be obtained prior to the catheterization. On the post-catheterization day, a repeat measurement will be obtained. Transient elastography will be performed by trained study investigators who were certified by the manufacturer.
To obtain an LSM, the appropriate-sized Fibroscan probe must be selected and then aimed in the right upper quadrant space through an intercostal space. For patients with heterotaxy or situs inversus, adjustments in probe positioning may be needed to obtain reliable measurement. Probe selection (small, medium, or large) will be directed by manufacturer guidelines, based on thoracic perimeter.
The operator is guided by an image to locate an appropriate section of liver. The Fibroscan device transmits an elastic shear wave through the hepatic parenchyma and then measures the propagation of the wave through a known distance of liver tissue to calculate a transmission velocity. Using the shear velocity and the mass density of the liver parenchyma, the principles of Young's modulus are invoked to estimate the Elasticity of the tissue. The elasticity is summarized as a liver stiffness measurement (LSM), which is a continuous variable that is reported in kilopascals (kPa). Each LSM outcome value is based on a minimum of ten valid assessments measured in succession. The validity of each individual measurement is determined by the device and the interquartile range of the measurements should fall within 30% of the median LSM. The Fibroscan data collection method is non-invasive and efficient. LSM will be obtained after fasting for a minimum of three hours and without administration of sedating agents/anesthetics.
108 studies on the registry are indexed under Univentricular Heart; 23 are open to participants now.
This study's enrollment of 16 is below the median of 48 across 45 observational studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 149 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.
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Any functional single-ventricle patients undergoing catheterization for Fontan fenestration closure will be invited to participate.
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Exclusion Criteria:
The exposure variable will be status of the Fontan fenestration
Immediate change in liver stiffness
Immediate change in Liver stiffness measurement (measured by Transient Elastography)he first measurement will be obtained on the day of the catheterization (for fenestration closure). The second measurement will be post-fenestration closure and will be obtained on the day after the catheterization.
Time frame: Patients will have measurements on day of catheterization and day after catheterization. They will be followed through study completion, an average of 6 months.
Short term change in liver stiffness
Short term change in Liver stiffness measurement (measured by Transient Elastography). The first measurement will be obtained on the day of the catheterization (for fenestration closure). The long-term outcome measurement will be obtained three months after the catheterization procedure.
Time frame: The first measurement will be obtained on the day of the catheterization (for fenestration closure). The long-term outcome measurement will be obtained three months afterwards. They will be followed through study completion, an average of 6 months.
Plan to share: No
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Ran from May 2018 to primary completion in Jun 2021, 37 months.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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