This application in response to RFA-HL-12-001 is to establish a Washington University Heart Failure Regional Clinical Center (HF-RCC), comprised of 5 clinical sites located throughout the state of Missouri. The proposed RCC will be capable of recruiting patients from a wide range of socioeconomic, gender, ethnic, and racial backgrounds, for acute and chronic trials heart failure trials in patients with systolic (SHF) and diastolic heart failure (DHF). Two additional components of this application are: A. Proposal for an early-phase randomized clinical trial (RCT) in patients with type 2 diabetes (T2D) and DHF, using a salsalate (SSA), an anti-inflammatory agent that improves glycemic control in T2D. The proposed placebo-controlled double-blind RCT in patients with T2D and DHF will test the hypothesis that modulation of inflammatory pathways by salsalate leads to improved left venricular end-diastolic filling pressures (detemined by echo-derived indices of LV diastolic function) and improved patient funtional capacity (determined by V02max). B. Proposal for a Clinical Research Skills Development Core (CRSDC) to train HF clinical investigators. There are three major objectives of the CRSDC: 1. Support two CRSDC Scholars/year to undergo training in clinical HF research by enrolling in a 2-year Masters of Science degree program. Scholars will gain clinical research skills through coursework, seminars, and one-on-one contact with a multidisciplinary group of faculty/mentors involved in clinical research. 2. Develop individualized mentored program in clinical HF research. This will include: a) completion of a mentored clinical HF research project; b) promote scholar career advancement through mentoring and guidance; c) prepare and submit a grant proposal; and d) evaluate scholars, mentors and CRSDC program. 3. Implement a HF-specific curriculum: a) weekly CV seminars; b) quarterly HF lecture series; c) yearly HF symposium; d) HF Visiting Professorship; and e) optional external rotations.
Proposal to participate as a Regional Clinical Center (RCC) in an NHLBI-sponsored heart failure network established to provide a program that will continue to provide support to develop, coordinate, and conduct multiple collaborative randomized clinical trials (RCTs) to improve HF outcomes. RCCs will provide scientific leadership In the collaborative development of the Network's scientific agenda.
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