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Clinical Trials/NCT02174133
NCT02174133
Completed
N/A

Impact of LVAD Implantation on Micro- and Macrovascular Function

Klinik für Kardiologie, Pneumologie und Angiologie1 site in 1 country60 target enrollmentJanuary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
End Stage Heart Failure
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Enrollment
60
Locations
1
Primary Endpoint
Macrovascular function measured by flow-mediated vasodilation (FMD)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
July 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible Party
Sponsor Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

Macrovascular function measured by flow-mediated vasodilation (FMD)

Time Frame: 3 months after implantation

Secondary Outcomes

  • microparticles determined by Flow Cytometry(3 months after implantation)
  • Microvascular function assessed by non-invasive laser Doppler imaging(3 months after implantation)

Study Sites (1)

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