Trial document





This trial has been registered retrospectively.
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  DRKS00015039

Trial Description

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Title

Early detection of Fontan-associated liver disease

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The Fontan operation is common surgical treatment for patients born with the single-ventricle type of congenital heart disease. Aim of this palliative procedure is the diversion of venous blood from inferior and superior vena cava to the pulmonary arteries to bypass a ventricular chamber.
Advances in diagnostic capacities, surgical techniques, and perioperative care have contributed to major improvements in patients outcome after the procedure. But there is growing evidence for end-organ dysfunctions related to the Fontan-circulation, especially affecting the liver. Patients after Fontan-palliation are prone to the development of liver fibrosis, liver cirrhosis and hepatocellular carcinoma.
For early detection of Fontan-associated liver disease we developed a diagnostic program including laboratory analysis and radiological investigations.
Aim of the study is to assess early signs of Fontan-associated liver disease.

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Brief Summary in Scientific Language

The Fontan operation is common surgical treatment for patients born with the single-ventricle type of congenital heart disease. Aim of this palliative procedure is the redirection of systemic venous return into the pulmonary arteries allowing passive venous flow in the pulmonary circulation without ventricular propulsion.
Advances in diagnostic capacities, surgical techniques, and perioperative care have contributed to major improvements in patients outcome after the procedure. But there is growing evidence for end-organ dysfunctions related to the Fontan-circulation, especially affecting the liver. Chronic venous congestion leads to chronic liver injury including liver fibrosis, liver cirrhosis and hepatocellular carcinoma.
For early detection of Fontan-associated liver disease we developed a diagnostic program including laboratory analysis and radiological investigations.
Aim of the study is to assess early signs of Fontan-associated liver desease and develop a diagnostic algorithm for early detection. Moreover, we want to analyse causes and risk factors for the development of Fontan-associated liver disease.

Therefore we extended our routinely performed Follow-up program for Fontan patients with the following examinations:

- 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 2 years)
- invasive measurement of liver pressure and liver vein wedge pressure during a routinely performed cardiac catheterization

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Organizational Data

  •   DRKS00015039
  •   2018/07/12
  •   [---]*
  •   yes
  •   Approved
  •   EA2/009/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1216-5635 
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Health Condition or Problem studied

  •   Q20.9 -  Congenital malformation of cardiac chambers and connections, unspecified
  •   K74.6 -  Other and unspecified cirrhosis of liver
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Interventions/Observational Groups

  •   - 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 2 years)
    - invasive measurement of liver pressure and liver vein wedge pressure during a routinely performed cardiac catheterization
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/09/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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Exclusion Criteria

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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • DHZB
    • Mr.  PD Dr. med.  Stanislav  Ovroutski 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   0304/ 593 2800
    •   0304/ 593 2900
    •   [---]*
    •   [---]*
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    • Deutsches Herzzentrum Berlin
    • Ms.  Dr. med.  Anastasia  Schleiger 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Deutsches Herzzentrum Berlin
    • Ms.  Dr. med.  Anastasia  Schleiger 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • DHZB
    • Mr.  PD Dr. med.  Stanislav  Ovroutski 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   0304/593 2800
    •   0304/593 2900
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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