Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices (EFECT LVAD) (EFECT-LVAD)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices|
- Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determine which markers are associated with Survival following LVAD [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine which markers are associated with quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Obtain pilot data on the acute endothelial response to exercise in patients with LVAD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Some of the blood collected at each visit will stored by the investigator for up to 5 years. Samples will be kept in our laboratory for up to 5 years as plasma, after which they will be destroyed. Samples will be identified only by a code number, only the principal investigator and his research staff will have access to the code. The results of the future tests will not be communicated to subjects in this study.
The samples are stored in the form of plasma from Peripheral blood for additional markers of endothelial function (Soluble thrombomodulin, IL-6, etc.)
|Study Start Date:||October 2010|
|Study Completion Date:||June 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233037
|United States, Minnesota|
|Fairview Health Systems Research|
|Minneapolis, Minnesota, United States, 555455|
|Principal Investigator:||Peter Eckman, MD||University of Minnesota - Clinical and Translational Science Institute|