Early detection of Fontan-associated liver disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015039

Enrollment

300

Registered

2018-07-12

Start date

2017-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q20.9 K74.6

Interventions

Group 1: - laboratory analysis including liver enzymes and Fibrotest (yearly) - liver ultrasound (age > 7 years, yearly/every 2 years) - transient elastography (Fibroscan, age > 14 years, yearly/every

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients after Fontan operation after completion of the 7th year of life.

Exclusion criteria

Exclusion criteria: All patients after Fontan operation who are younger than 7 years.

Design outcomes

Primary

Measure	Time frame
Primary outsome: Early detection of Fontan-associated liver disease. Results from liver specific blood analysis (Fibrotest), liver ultrasound, transient elastography (Fibroscan), invasive measurement of Fontan pressure and liver vein wedge pressure.	—

Secondary

Measure	Time frame
Secondary outcomes: Hepatic changes measured by liver specific blood tests and radiological investigations in relation to duration of the Fontan circulations.	—

Countries

Germany

Contacts

Public ContactAnastasia Schleiger

Deutsches Herzzentrum Berlin

schleiger@dhzb.de0304/5932800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026