The Effect of Fontan Fenestration Closure on Hepatic Stiffness

NCT03481985 | Completed

• 1 other identifier: IRB-P00027110
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Single-ventricle; Hepatic Congestion

Keywords

Fontan-associated liver disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Patients will have measurements on day of catheterization and day after catheterization. They will be followed through study completion, an average of 6 months.

Secondary Outcomes (1)

• Short term change in liver stiffness

  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.

Interventions

Fenestration status OTHER

The exposure variable will be status of the Fontan fenestration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any functional single-ventricle patients undergoing catheterization for Fontan fenestration closure will be invited to participate.

You may qualify if:

• 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

You may not qualify if:

• Patients with spontaneous closure of Fenestration
• Ascites
• Ventilatory requirement
• Implantable cardiac device
• Ongoing inotropic support
• Pregnancy
• Inability to tolerate four hour pre-procedure fasting

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rahul Rathod, MD

  Cardiologist/Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 29, 2018
• Study Start: May 29, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)