Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008376

Trial Description

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Title

Impact of LVAD Implantation on Micro- and Macrovascular Function

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Trial Acronym

LVAD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

End stage heart failure is characterized by a critical inability of the heart to meet the
organism's blood demand even under resting conditions. Heart transplantation (HTx) is the
established therapeutic approach in the treatment of end stage heart failure and still the
gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital
therapeutic option to temporarily or permanently assist the failing circulation. The
hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The
aim of the study is to investigate the effect of LVAD implantation compared to heart
transplant (HTx) on micro- and macrovascular function in patients with end stage heart
failure.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008376
  •   2016/03/11
  •   2014/06/24
  •   yes
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Secondary IDs

  •   NCT02174133  (ClinicalTrials.gov)
  •   LVAD  (Klinik für Kardiologie, Pneumologie und Angiologie)
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Health Condition or Problem studied

  •   End Stage Heart Failure
  •   I50 -  Heart failure
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Macrovascular function measured by flow-mediated vasodilation (FMD); time frame: 3 months after implantation

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Secondary Outcome

- Microvascular function assessed by non-invasive laser Doppler imaging; time frame: 3 months after implantation
- microparticles determined by Flow Cytometry; time frame: 3 months after implantation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/01/31
  •   60
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Inclusion Criteria

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

- patients after HTX

- patients after LVAD implantation

- patients with stable coronary heart disease and normal systolic left ventricular
function

- healthy volunteers

- written informed consent

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Exclusion Criteria

- acute inflammation

- cardiac arrhythmia

- renal failure

- malignant disease

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Kardiologie, Pneumologie und Angiologie
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    •   [---]*
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    • Division of Cardiology, Pulmonology and Vascular Medicine
    • Christian Heiss, MD 
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    • Division of Cardiology, Pulmonology and Vascular Medicine
    • Christian Heiss, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.