The clinical investigations outlined in this Project are designed to test the hypothesis that direct intramyocardial injections of naked DNA encoding for vascular endothelial growth factor (phVEGF165) in patients with advanced heart failure is safely tolerated and may in some patients lead to improvement in their clinical status. The clinical trials that we have proposed incorporate a strategy that is designed to address patients in whom all medial measures to treat advanced congestive heart failure (CHF) have failed, leaving these patients in need of cardiac transplantation. Owing to the mismatch that currently exists between the number of patients in need of cardiac transplantation and the number of available donors, implantation of a left ventricular assist device (LVAD) Is often required for patients as a so- called """"""""bridge"""""""" to transplantation. It is this population of patients-those undergoing LVAD implantation for advanced heart failure-that re intended to be addressed in the current Proposal. For the purpose of our clinical studies, these patients have been divided into two large subgroups, based on associated evidence on extramural coronary artery disease (CAD). Accordingly, the specific aims of this Proposal are as follows: 1.
Specific Aim #1 : To evaluate the safety and impact of phVEGF/165 gene transfer on LV function in patients with CHF due to coronary artery disease. 2.
Specific Aim #2 : To evaluate the safety and impact of phVEGF165 gene transfer on LV function in patients with CHF due to idiopathic dilated cardiomyopathy, excluding patients with significant narrowing of the extramural coronary arteries of primary valvular heart disease. 3. Sp4ecific Aim #3: To evaluate the efficacy of phVEGF gene transfer to allow for LVAD bridge-to-recovery (BTR) as an alternative to transplantation.
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