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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03914196
The ClinicalTrials.gov registry entry for NCT03914196 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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