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Impact of LVAD Implantation on Micro- and Macrovascular Function

Completed
Conditions
End Stage Heart Failure
Registration Number
NCT02174133
Lead Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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
Exclusion Criteria
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • malignant disease

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Macrovascular function measured by flow-mediated vasodilation (FMD)3 months after implantation
Secondary Outcome Measures
NameTimeMethod
microparticles determined by Flow Cytometry3 months after implantation
Microvascular function assessed by non-invasive laser Doppler imaging3 months after implantation

Trial Locations

Locations (1)

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

🇩🇪

Duesseldorf, Germany

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