Trial document




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  DRKS00000340

Trial Description

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Title

Gender Differences in Aortic Stenosis II

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Trial Acronym

GUAS II

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URL of the Trial

http://gender.charite.de/

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Brief Summary in Lay Language

Women with aortic stenosis (AS) before aortic valve replacement (AKE) have more preoperative left ventricular hypertrophy than men, and left ventricular hypertrophy regresses more rapidly after surgery in women than men. In myocardial biopsies from 46 patients, we were able to show changes in gene expression in the fatty acid and glucose oxidation as well as gender differences in markers of tissue synthesis. Men compared with women showed a stronger induction of collagen gene expression and matrix metalloproteinases. These findings should be confirmed in larger patient numbers and at protein level in a new study. In addition, the molecular mechanisms for the faster regression of hypertrophy in women should be identified.

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Brief Summary in Scientific Language

Women with aortic stenosis (AS) before aortic valve replacement (AKE) have more preoperative left ventricular hypertrophy than men, and left ventricular hypertrophy regresses more rapidly after surgery in women than men. In myocardial biopsies from 46 patients, we were able to show changes in gene expression in the fatty acid and glucose oxidation as well as gender differences in markers of tissue synthesis. Men compared with women showed a stronger induction of collagen gene expression and matrix metalloproteinases. These findings should be confirmed in larger patient numbers and at protein level in a new study. In addition, the molecular mechanisms for the faster regression of hypertrophy in women should be identified.
Because the estrogen-dependent interaction of estrogen receptor alpha (ERá) with myocardial structural proteins and enzymes of fatty acid metabolism could explain gender differences in cardiac function, we systematically investigated the interaction partners of ERá in the myocardium.

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Organizational Data

  •   DRKS00000340
  •   2010/03/15
  •   [---]*
  •   yes
  •   Approved
  •   EA2/010/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1113-9308 
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Health Condition or Problem studied

  •   I35.0 -  Aortic (valve) stenosis
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Interventions/Observational Groups

  •   after informed consent, a tissue sample from LV myocardium is obtained during surgery from all patients with signifcant LV outflow tract obstruction
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Characteristics

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

myocardial Genex epression. arbitrary units; intra - surgery, by PCR || myocardial Genex epression. arbitrary units

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/08/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

AS II-IV Patients in need of surgery,> 18 Yrs, consent after oral and written information and agreement

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Exclusion Criteria

Coronary heart disease, hemodynamically effective congenital heart defects, or additional cardiovascular disease in addition to aortic stenosis, malignant systemic diseases

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Addresses

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    • Deutsches Herzzentrum Berlin DHZB
    • Ms.  Prof. Dr. med.  Vera  Regitz-Zagrosek 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Geschlechterforschung in der Medizin, Charite und DHZB
    • Ms.  Prof. Dr. med.  Vera  Regitz-Zagrosek 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Institut für Geschlechterforschung in der Medizin, Charite und DHZB
    • Ms.  Prof. Dr. med.  Vera  Regitz-Zagrosek 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • DFG - Deutsche Forschungsgemeinschaft Lebenswissenschaften I
    • Mr.  Dr.  Tobias  Grimm 
    • Kennedyallee 40
    • 53175  Bonn
    • 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.