Trial document




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  DRKS00012508

Trial Description

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Title

Functional analysis of the adaptive immune system in patients with congestive heart failure

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Trial Acronym

FACH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A higher susceptibility for upper respiratory tract infections and pneumonia is a long standing clinical problem in patients with congestive heart failure and contributes significantly to morbidity and mortality. About 1/5 of patients listed for heart transplantation and suffering from heart failure show low levels of antibodies (hypogammaglobulinemia) and decreased lymphocyte counts. This goes along with a higher infection risk. Still, the prevalence of hypogammglobulinemia in heart failure patients not listed for heart transplantation is unknown. Furthermore immunological data of those patients have not yet been assessed, although they are of high clinical relevance because immunoglobulin substitution could be an effective treatment.
Therefore we aim to characterize in detail immunological data of patients suffering from congestive heart failure. In context with the AWIS-study Nieters et al. developed a validated self-reported questionnaire regarding infection risk in the general population. Using this questionnaire, we will assess the susceptibility to upper respiratory tract infections in our trail population and correlate it with their immunological data to finally compare it to the general population. Eventually our data could help to develop a simple screening tool for patients with congestive heart failure an high infection risk.

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Brief Summary in Scientific Language

Congestive heart failure (CHF) is a common disorder and susceptibility to respiratory tract infections contributes significantly to its high morbidity and mortality. Lymphopenia and hypogammaglobulinemia have been reported in patients with congestive heart failure. The latter has been correlated with a higher infection risk. But its pathophysiology is not well understood and the majority of patients do not undergo systematic screening for secondary immunodeficiency despite the availability of immunoglobulin substitution which is an effective treatment for hypogammaglobulinemia.
Our trial population will consist of about 150 patients either listed for cardiac transplantation or suffering from symptomatic CHF (NYHA II-IV) or having a congenital heart defect with remaining CHF. At our center Nieters et al developed and validated a self-reported questionnaire to assess the susceptibility to respiratory tract infections in the normal population. We will use this questionnaire to formally assess the infectious burden in patients with CHF and compare it to the data from the normal population. We will further characterize the adaptive immune system in CHF patients by measuring quantitative immunoglobulins and lymphocyte subpopulations and compare them to the normal population. CHF patients with hypogammaglobulinemia and lymphopenia will be further sub characterized with vaccination responses, immunoglobulin subclasses, T lymphocyte and B lymphocyte subpopulations. The immunologic results will be correlated to the infectious symptom burden.
This study aims to establish an easy screening tool for CHF patients to assess infectious susceptibility and immunologic abnormalities. This could translate into future supportive therapies in CHF patients.

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Organizational Data

  •   DRKS00012508
  •   2017/07/06
  •   [---]*
  •   yes
  •   Approved
  •   224/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Congestive Heart Failure
    Adults with Congenital Heart Defects
  •   Q20-Q28 -  Congenital malformations of the circulatory system
  •   I50.9 -  Heart failure, unspecified
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Interventions/Observational Groups

  •   Patients with congestive heart failure will be assessed for infectious susceptibility with a self-reported questionnaire and immunologic parameters (immunoglobulin, lymphocytes) will be measured in the peripheral blood. This will be compared to data from the general population.
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Characteristics

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

Comparison of the RTI-score and corresponding immunologic data (Ig levels, lymphocyte counts, vaccination responses) between the trial population and the general population included into the AWIS cohort.

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Secondary Outcome

Correlation of RTI-score and hypogammaglobulinemia (defined als IgG levels <7mg/dl) in the trial population.
Distribution of B lymphocyte subpopulations in the trial population with hypogammaglobulinemia compared to patients within the trial population with normal Ig values.
Frequency of protective antibody titers against pneumococcal antigens in the trial population with hypogammaglobulinemia compared to patients within the trial population with normal Ig values.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/07/11
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

-Adult patients listed for cardiac transplantation at the UHZ Freiburg.
-Adult patients with CHF NYHA II-IV attending the UHZ Freiburg for various reasons
-Adult patients with congenital heart defects at the UHZ Freiburg and one of the following:
Eisenmenger syndrome or history of Fontan´s procedure or ≥ NYHA II

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Exclusion Criteria

absence of consent

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Centrum für Chronische Immundefizienz,Universitätsklinikum Freiburg
    • Ms.  PD Dr.  Alexandra  Nieters 
    • Breisacher Str. 115
    • 79106  Freiburg
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    • Centrum für Chronischer Immundefizienz, Universitätsklinikum Freiburg
    • Ms.  PD Dr.  Alexandra  Nieters 
    • Breisacherstr. 115
    • 79106  Freiburg
    • Germany
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    • Centrum für Chronischer Immundefizienz, Universitätsklinikum Freiburg
    • Ms.  Dr.  Claudia  Wehr 
    • Breisacherstr. 115
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.