Liver fibrosis associated with Fontan circulation - evaluation of diagnostic methods and potential risk factors

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024083

Enrollment

100

Registered

2021-01-19

Start date

2019-04-08

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Fontan circulation Q23.4 Q22.4 Q20.4 Q22.6

Interventions

Group 1: Detailed evaluation of the liver in Fontan patients (Ultrasound, Elastography, MRI, blood test) Group 2: Elastography and MRI in healthy probands

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: Fontan circulation

Exclusion criteria

Exclusion criteria: Contraindications for MRI, ferromagnetic implants, pacemaker

Design outcomes

Primary

Measure	Time frame
Evaluation of non-invasive diagnostics methods for characterisation of Fontan associated liver fibrosis. Shearwave elastography non-contrast enhanced MRI (T1 and T2 mapping, diffusion weighted imaging, 4D flow, spectroscopy) Laboratory parameters Comparison with routine diagnostics	—

Secondary

Measure	Time frame
Evaluation of risk factors for liver fibrosis	—

Countries

Germany

Contacts

Public ContactJan Hinnerk Hansen

Universitätsklinikum Schleswig-Holstein Campus Kiel

janhinnerk.hansen@uksh.de043150025647

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026