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NCT03481985

The Effect of Fontan Fenestration Closure on Hepatic Stiffness

Completed Last updated 19 April 2023
What this trial tests

trial testing Fenestration status in Single-ventricle in 16 participants. Completed in 30 June 2022.

Timeline
29 May 2018
Primary endpoint
30 June 2021
30 June 2022

Quick facts

Lead sponsorBoston Children's Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment16
Start date29 May 2018
Primary completion30 June 2021
Estimated completion30 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston Children's Hospital

Who can join

Eligibility, any sex, with Single-ventricle or Hepatic Congestion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Single-ventricle

Currently open trials in the same condition.

Other Boston Children's Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03481985.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing