Trial document




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  DRKS00004898

Trial Description

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Title

Heartfailure in geriatrics. Usefullness of arterial preassure response during valsalva test as a measure of heartfailure

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Trial Acronym

VALGER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Registration of the blood pressure response during Valsalva test. Three types of preassure response may occur: A (decrease of blood preassure during Testing and rebound increase following termination of pressing), B (short increase in blood pressure and a lack of increase after termination of pressing) and C (sustained increase in blood pressure during pressing).

A blood value, the so-called pBNP is a marker of the severity of heart failure.

The blood pressure response during pressing is compared with the value of pBNP that is determined at the same time. The examiner is blinded to to the pBNP value at the time of blood pressure measurement.

We expect significantly increased pBNP value in patients with type C reaction

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Brief Summary in Scientific Language

Determination of pBNP value for the objective detection of heart failure.
Performing the Valsalva test with simultaneous registration and systolic blood pressures and classification of blood pressure reaction according to type A (hypotension and rebound following termination of the maneuver), type B (short increase in blood pressure without rebound after termination of the maneuver) or type C ( elevated blood preassure during the maneuver)

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Organizational Data

  •   DRKS00004898
  •   2013/05/27
  •   [---]*
  •   yes
  •   Approved
  •   2013055, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   U1111-1143-5119 
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Health Condition or Problem studied

  •   I50.9 -  Heart failure, unspecified
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Interventions/Observational Groups

  •   Blood pressure measurement during a Valsalva test. Classification of blood pressure response according to type A (decrease of Blood pressure during valsalva testing, rebound increase of blood pressure at termination of valsalva testing), type B (short increase of blood pressure during Valsalva Testing, no increase of blood pressure at termination of Valsalva testing), type or C (persitent increase of bloofd pressure during Valsalva testing).

    Determination of pBNP value in serum.
    Statitical analysis of the relationship between the type of response of the blood pressure and the pBNP value
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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

Correlation between response of blood pressure during Valsalva testing and the pBNP-value

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/06/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

geriatric patient in a stable clinical condition

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Exclusion Criteria

unstable clinical condition, terminal clinical condition

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • 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.