Principal Investigator/Program Director (Last, first, middle): Chen, Frederick, Y RESEARCH &RELATED Other Project Information 1. * Are Human Subjects Involved? m Yes l No 1.a. If YES to Human Subjects Is the IRB review Pending? m Yes m No IRB Approval Date: Exemption Number: 1 2 3 4 5 6 Human Subject Assurance Number 2. * Are Vertebrate Animals Used? l Yes m No 2.a. If YES to Vertebrate Animals Is the IACUC review Pending? m Yes l No IACUC Approval Date: 07-14-2006 Animal Welfare Assurance Number A3431-01 3. * Is proprietary/privileged information m Yes l No included in the application? 4.a.* Does this project have an actual or potential impact on m Yes l No the environment? 4.b. If yes, please explain: 4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or environmental impact statement (EIS) been performed? m Yes m No 4.d. If yes, please explain: 5.a.* Does this project involve activities outside the U.S. or m Yes l No partnership with International Collaborators? 5.b. If yes, identify countries: 5.c. Optional Explanation: 6. * Project Summary/Abstract 1562-Project_Summary.pdf Mime Type: application/pdf 7. * Project Narrative 611-Project_Narrative.pdf Mime Type: application/pdf 8. Bibliography &References Cited 6320-Literature_Cited.pdf Mime Type: application/pdf 9. Facilities &Other Resources 3342-Resources.pdf Mime Type: application/pdf 10. Equipment 5580-Equipment.pdf Mime Type: application/pdf Tracking Number: Other Information Page 5 OMB Number: 4040-0001 Expiration Date: 04/30/2008 Principal Investigator/Program Director (Last, first, middle): Chen, Frederick, Y Project Summary/Abstract Heart failure is a deadly epidemic with few therapeutic options. Ventricular restraint represents a promising non-transplant treatment currently in clinical trials. In this surgery, the heart is wrapped with passive material to prevent it from dilating and remodeling. Currently, there is no methodology to measure or adjust restraint therapy level. No studies exist correlating restraint level to therapy efficacy or mechanism. Therapy is applied subjectively. This may ultimately limit overall effectiveness and impair safety. To address this, an adjustable, fluid-filled balloon was developed to quantitatively apply restraint to the entire ventricular epicardial surface. The long-term goals of this project are to quantitate how ventricular restraint influences the remodeling process and to identify rational criteria for improved therapy efficacy by applying restraint in a measurable and adjustable manner. By applying measurable, adjustable restraint with this unique restraint device to an ischemic ovine model of dilated cardiomyopathy, Specific Aim #1 will measure the acute and subacute effects of restraint level on remodeling pathophysiology.
In Specific Aim #2, the chronic effects of restraint on remodeling will be quantitated, and an optimal restraint level will be identified.
Specific Aim #3 will investigate whether measurable, adjustable restraint therapy results in increased reverse remodeling compared to standard, non-adjustable restraint therapy.
These specific aims are designed to provide a comprehensive quantification of the effect of restraint level on ventricular pathophysiology and remodeling. By measuring cause and effect with respect to restraint and reverse remodeling for the first time, these studies may provide an entire new approach to ventricular restraint that may lead to significant advance in the armamentarium against heart failure. Project Description Page 6
