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Understanding Liver Disease After Fontan Surgery

This observational study aims to better understand Fontan Associated Liver Disease (FALD), a condition where blood congestion in the liver after a Fontan procedure can lead to severe scarring (cirrhosis). Researchers want to learn how this congestion causes cirrhosis and identify new ways to measure how severe the disease is. The study will involve people aged 18 and older who have had a Fontan procedure and are at risk for FALD. There are no specific interventions being tested. The main goal is to understand how liver congestion leads to cirrhosis in FALD.

Study design
This is an observational study with a planned enrollment of up to 100 participants. It is not specified if it is randomized or blinded.
What's involved
You will have a screening with a medical history, physical exam, blood and urine tests, and a liver ultrasound. You will then have an outpatient visit within 12 weeks, followed by a 3-day hospital stay within 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at the end of the study, but the duration of follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05213598

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

Recruiting
Not specifiedAges 18+Observational
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~100 participants
Updated 2026-09-03 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To generate understanding of how congestive hepatopathy drives the pathogenesis of cirrhosis in FALD
Measured over End of Study

Conditions

Congenital Heart Disease

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NCT05213598

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Elenita M Rivera, R.N.
[email protected]
(301) 435-6125
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • To generate understanding of how congestive hepatopathy drives the pathogenesis of cirrhosis in FALDEnd of Study

    Identification of novel biomarkers correlating with disease progression markers in Fontan Associated Liver Disease Develop an understanding of the biological mechanisms and the genetic modifiers of the progression of Fontan Associated Liver Disease