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NCT03914196 · ClinicalTrials.gov registry record
Fontan Associated Liver Disease
A clinical trial of Fontans, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT03914196: Active study of Fontans, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03914196 is a study of Fontans that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03914196, a study of Fontans, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Fontan-associated liver disease (FALD), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the Fontan operation. However, the specific phenotype (fibrosis only, fibrosis + lesions, etc.) of disease and severity/timing of onset are variable. Chronic passive congestion of the liver due to the absence of a functional sub-pulmonary ventricle and resultant chronic central venous hypertension is suspected to be one of the chief drivers of FALD and recent work has demonstrated that ultrasound shear wave elastography can be used to noninvasively detect and measure the degree of liver congestion. Chronic passive congestion of the liver may also be a predictor of other Fontan-related complications, such as protein losing enteropathy, plastic bronchitis, and intractable ascites.
Primary Outcome
to determine if there are differences between patients with regard to liver stiffness (hepatic congestion) pre- and post-Fontan operation or with regard to change in liver stiffness over time. This information will be used to drive future hypothesis-driven research related to predicting Fontan-related outcomes based on measured liver stiffness.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Liver Stiffness Ultrasound
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2028-12-31 |
What the registry record for NCT03914196 still lists
NCT03914196 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Fontans appearing as the primary indexed condition, and to 1 intervention - of which Liver Stiffness Ultrasound is the first listed.
NCT03914196 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03914196 about?
NCT03914196 is a clinical study titled "Fontan Associated Liver Disease". Fontan-associated liver disease (FALD), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the Fontan operation. However, the specific phenotype (fibrosis only, fibrosis + lesions, e...
What is the current status of trial NCT03914196?
This trial is currently active not recruiting. The enrollment target is 50 participants. The study started on 2018-01-18. Estimated completion is 2028-12-31.
What conditions does trial NCT03914196 study?
This clinical trial studies the following conditions: Fontans.
What interventions are being tested in trial NCT03914196?
The interventions under investigation include: Liver Stiffness Ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03914196?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03914196 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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