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NCT03481985 · ClinicalTrials.gov registry record

The Effect of Fontan Fenestration Closure on Hepatic Stiffness

A clinical trial of Single-ventricle and Hepatic Congestion, sponsored by Boston Children's Hospital.

Completed
Registry status
16
Enrollment target
1
Study location

NCT03481985 is a study of Single-ventricle and Hepatic Congestion that has completed, run by Boston Children's Hospital. The registered enrollment target is 16 participants, below the 86-participant average among 17 other Single-ventricle trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03481985, a study of Single-ventricle and Hepatic Congestion, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
16 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • OTHER Fenestration status

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2018-05-29
Est. Completion 2022-06-30

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT03481985

The ClinicalTrials.gov registry entry for NCT03481985 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 17 other Single-ventricle trials with a reported enrollment target (81% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Single-ventricle appearing as the primary indexed condition, and to 1 intervention - of which Fenestration status is the first listed.

NCT03481985 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03481985 about?

NCT03481985 is a clinical study titled "The Effect of Fontan Fenestration Closure on Hepatic Stiffness". 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 measurement...

What is the current status of trial NCT03481985?

This trial is currently completed. The enrollment target is 16 participants. The study started on 2018-05-29. Estimated completion is 2022-06-30.

What conditions does trial NCT03481985 study?

This clinical trial studies the following conditions: Single-ventricle, Hepatic Congestion.

What interventions are being tested in trial NCT03481985?

The interventions under investigation include: Fenestration status (OTHER).

Who is sponsoring clinical trial NCT03481985?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03481985 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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