Endothelial Cells, Exercise Tolerance
Conditions
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Minnesota
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation. | 3 years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed