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Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment

NCT05213598 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Theo Heller, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2051-06-30
Completion
2051-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05213598 on ClinicalTrials.gov