We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Fontan Fenestration Closure on Hepatic Stiffness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481985
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Rahul Rathod, Boston Children's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Single-ventricle Hepatic Congestion Other: Fenestration status

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Fontan Fenestration Closure on Hepatic Stiffness
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Fenestration status
    The exposure variable will be status of the Fontan fenestration

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immediate change in liver stiffness [ 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. ]
    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.


Secondary Outcome Measures :
  1. Short term change in liver stiffness [ 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. ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any functional single-ventricle patients undergoing catheterization for Fontan fenestration closure will be invited to participate.
Criteria

Inclusion Criteria:

  • Functional Single ventricle patients after a fenestrated lateral tunnel or extra-cardiac Fontan
  • Patients scheduled for possible fenestration closure in the catheterization laboratory
  • Informed consent has been obtained

Exclusion Criteria:

  • Patients with spontaneous closure of Fenestration
  • Ascites
  • Ventilatory requirement
  • Implantable cardiac device
  • Ongoing inotropic support
  • Pregnancy
  • Inability to tolerate four hour pre-procedure fasting
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT03481985


Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Rahul Rathod, MD Cardiologist/Principal Investigator
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rahul Rathod, Cardiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03481985    
Other Study ID Numbers: IRB-P00027110
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rahul Rathod, Boston Children's Hospital:
Fontan-associated liver disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Univentricular Heart
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities