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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices

Conditions
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Endothelial Cells, Exercise Tolerance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced heart failure and scheduled LVAD implantation for standard clinical indications. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: Inability to personally provide informed consent Medical activity restriction that precludes ambulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine which markers are associated with Survival following LVAD |  | 3 years | 
| To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs |  | 3 years | 
| Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant |  | 5 years | 
| Determine which markers are associated with quality of life |  | 5 years | 
| Obtain pilot data on the acute endothelial response to exercise in patients with LVAD |  | 2 years |