SALsalate to Improve Exercise toleraNce and LVDD in T2dm-DHF (SALIENT-DHF trial)

响应RFA-HL-12-001的本申请旨在建立一个华盛顿大学心力衰竭 区域临床中心（HF-RCC），由遍布密苏里州的5个临床研究中心组成。 拟议的RCC将能够从广泛的社会经济、性别、 种族和人种背景，用于收缩压（SHF）患者的急性和慢性试验心力衰竭试验 舒张性心力衰竭（DHF）。此应用程序的两个附加组件是： A.在2型糖尿病（T2 D）患者中开展早期随机临床试验（RCT）的提案， DHF，使用双水杨酸酯（SSA），一种改善T2 D血糖控制的抗炎药。 在T2 D和DHF患者中拟定的安慰剂对照双盲RCT将检验假设 双水杨酸对炎症通路的调节可改善左心室舒张末期充盈 压力（由LV舒张功能的回声衍生指数确定）和改善患者功能 容量（由V02 max确定）。 B。临床研究技能发展核心（CRSDC）培训HF临床研究者的提案。 委员会有三个主要目标：1.每年支持两名CRSDC学者接受以下培训： 通过参加为期2年的理学硕士学位课程进行临床HF研究。学者将获得临床 研究技能，通过课程，研讨会，和一对一的接触与多学科小组的 参与临床研究的教师/导师。2.开展临床心力衰竭的个体化指导计划 research.这将包括：a）完成指导临床HF研究项目; B）促进学者 通过辅导和指导促进职业发展; c）准备并提交赠款提案;以及d） 评估学者，导师和CRSDC计划。3.实施针对保健基金的课程： 研讨会; B）HF季度讲座系列; c）HF年度研讨会; d）HF访问教授;以及e） 可选的外部旋转。

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.