Expired Study
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Minneapolis, Minnesota


Purpose:

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 summary:

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.


Criteria:

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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


NCT ID:

NCT01233037


Primary Contact:

Principal Investigator
Peter Eckman, MD
University of Minnesota - Clinical and Translational Science Institute


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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