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Liver Stiffness of Teens, Adults and Fontan-Patients effected by Body Position

Liver Stiffness of Teens, Adults and Fontan-Patients effected by Body Position

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036639
Enrollment
40
Registered
2025-04-11
Start date
2025-04-01
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

Q24.8

Interventions

Group 1: First group: Patients with completed Fontan surgery, male, female, ages 15-25 Exclusion criteria for healthy volunteers: Liver diseases (e.g., liver fibrosis, liver cirrhosis, infectious dis

Sponsors

LMU Klinikum Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 20 Years

Inclusion criteria

Inclusion criteria: First group: Patients with completed Fontan surgery, male, female, ages 15-25 Second group: Normal population: healthy male and female subjects between 15-25 years of age without previous cardiovascular diseases or liver diseases, normal weight

Exclusion criteria

Exclusion criteria: Exclusion criteria for Fontan patients: none Exclusion criteria for healthy volunteers: Liver diseases (e.g., liver fibrosis, liver cirrhosis, infectious diseases, liver tumors), other vascular diseases (elevated CVP), cardiovascular diseases (e.g., cardiac arrhythmias, hypertension, heart failure), metabolic diseases (e.g., hyperthyroidism, glucose metabolism disorders), gastrointestinal diseases (e.g., gallbladder disease, gallstones, biliary obstruction), kidney diseases, nervous system diseases, mental illnesses, regular drug use including nicotine and alcohol, obesity, volunteers taking regular medication (except contraceptives), pregnant women.

Design outcomes

Primary

MeasureTime frame
Liverstiffness measured while standing up and lying down When: See below for exact times. How: Liver elastography measurement Preparation: (approx. 30 minutes) The subject arrives at the scheduled appointment after breakfast. The patient does not need to be fasting. The subject/patient information and a detailed medical consultation will be provided. The risk factors mentioned above and a detailed medical history will be reviewed to identify possible exclusion criteria. Liver examination: (time required: approximately 2 hours) The first measurement is taken after a 30-minute lying period (T0). The patient is then asked to stand up. Measurements are taken while standing 15, 30, 45, and 60 minutes later. Finally, another measurement is taken while lying down, measured 75 and 90 minutes after the first examination. The following data is recorded using an examination form: height, weight, age, blood pressure, non-invasive cardiac output, previous illnesses, and medication intake. Liver stiffness is measured using liver elastography at the times specified above in the respective position. Additionally, the diameter of the inferior vena cava and blood flow in the aforementioned vessels are visualized via ultrasound.

Countries

Germany

Contacts

Public ContactNikolaus Haas

LMU Klinikum Großhadern

nikolaus.haas@med.uni-muenchen.de+49 89 4400 73941

Outcome results

None listed

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