Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices (EFECT LVAD)
Completed
Conditions studied: Endothelial Cells, Exercise Tolerance
In brief
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.
Key facts
- Study ID
- NCT01233037
- Run by
- University of Minnesota
- People needed
- 20
- Starts
- 2010-10-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
You may not qualify if…
- Inability to personally provide informed consent
- Medical activity restriction that precludes ambulation
Where it is running
- Fairview Health Systems Research — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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