Actively Recruiting
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
100
Participants Needed
1
Research Sites
1503 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: In Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it. Objective: To understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis. Eligibility: People aged 18 and older who are at risk of developing FALD from the Fontan procedure. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Liver ultrasound. This uses sound waves to take pictures of the body. Participants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit. Visits will include repeats of the screening tests and: Heart tests Stool collection Questionnaires MRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct. Fibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver. Upper endoscopy. This uses a thin scope to look inside the upper digestive tract. Liver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.
CONDITIONS
Official Title
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects 18 years of age or older
- History of Fontan surgical procedure
- Prior enrollment in Liver Diseases Branch protocol 91DK0214
- Cardiac catheterization or transjugular liver biopsy done within 10 years before screening
- Approval by NIH Cardiology Consult
- Approval by NIH Cardiac Pre-anesthesia Consult
You will not qualify if you...
- Other liver diseases that cause cirrhosis
- Active chronic Hepatitis B infection with high viral load
- Presence of hepatitis C RNA in serum
- Liver diseases such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis
- Hemochromatosis defined by liver biopsy iron staining or genetic testing
- Bile duct obstruction shown by imaging in last 6 months
- Active substance abuse within the past year
- Evidence of hepatocellular carcinoma or cholangiocarcinoma
- Severe allergic reaction to contrast
- Any severe condition preventing study participation
- Radiation exposure exceeding 5 rems in the past year
- Inability to comply or give informed consent
- Pregnancy in female subjects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
E
Elenita M Rivera, R.N.
CONTACT
T
Theo Heller, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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