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Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices (EFECT LVAD)

NCT01233037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2016-08-05

No results posted yet for this study

Summary

This is a non-randomized feasibility study of endothelial function, exercise capacity, and outcome following pre-left ventricular assist device (LVAD)therapy and cardiac transplant.

The study period will be 5 years, with 20 patients to be enrolled. The investigators anticipate that 15 patients will survive to complete the one year follow up period.(the published survival rate of LVAD is 75% in one year). 10 patients are anticipated to undergo cardiac transplant within 3 years of initial enrollment and they are followed until their 2nd annual post transplant invasive evaluation.

Markers of endothelial function will be studied to permit comparison with selected clinical outcomes. The hypothesis is that the endothelial functions will be altered after implantation of LVAD then before its implantation, both acutely and chronically, and this may affect the exercise capacity, quality of life and occurrence of cardiac allograft vasculopathy post cardiac transplantation.

Conditions

  • Endothelial Cells
  • Exercise Tolerance

Sponsors & Collaborators

Principal Investigators

  • Peter Eckman, MD · University of Minnesota

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-11-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233037 on ClinicalTrials.gov