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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: Completed study of Single-ventricle and Hepatic Congestion, sponsored by Boston Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Fenestration status
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2022-06-30 |
What the finished NCT03481985 record still lists
NCT03481985 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 86-participant average among 17 other Single-ventricle trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03481985's enrollment target sits among peer trials
16 16th of 17 higher than 2 of 17 other Single-ventricle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Single-ventricle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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