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Impact of LVAD Implantation on Micro- and Macrovascular Function (LVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174133
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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.

Condition or disease
End Stage Heart Failure

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of LVAD Implantation on Micro- and Macrovascular Function
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
patients after HTX
patients after LVAD implantation
patients with coronary heart disease
healthy volunteers



Primary Outcome Measures :
  1. Macrovascular function measured by flow-mediated vasodilation (FMD) [ Time Frame: 3 months after implantation ]

Secondary Outcome Measures :
  1. Microvascular function assessed by non-invasive laser Doppler imaging [ Time Frame: 3 months after implantation ]
  2. microparticles determined by Flow Cytometry [ Time Frame: 3 months after implantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with end stage heart failure
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174133


Locations
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Germany
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
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Principal Investigator: Christian Heiss, MD Division of Cardiology, Pulmonology and Vascular Medicine
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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02174133    
Other Study ID Numbers: LVAD
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
left ventricular assist device
endothelial function
microvascular perfusion
microparticles
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases