Exercise Tolerance Clinical Trial
Official title:
Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices
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.
This is a non-randomized, feasibility study of endothelial function, exercise capacity, and
outcome following pre-LVAD patients through LVAD therapy and cardiac transplantation.
The study period will be 5 years. It is anticipated that 20 patients will be enrolled and 15
will survive (published survival estimate following LVAD is approximately 75% at one year)
to complete the one-year follow-up period. 10 patients are anticipated to undergo heart
transplant within 3 years of initial enrollment and they will be followed until their 2nd
annual post-transplant invasive evaluation.
;
Observational Model: Case Control, Time Perspective: Prospective
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