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

描述(由申请人提供)：本申请响应RFA-HL-12-001，旨在建立华盛顿大学心力衰竭区域临床中心(HF-RCC)，该中心由密苏里州5个临床站点组成。拟议的RCC将能够招募来自广泛的社会经济、性别、民族和种族背景的患者，用于心脏收缩衰竭(SHF)和舒张期心力衰竭(DHF)患者的急性和慢性试验。该申请的另外两个组成部分是：A.建议对2型糖尿病(T2D)和DHF患者进行早期随机临床试验(RCT)，使用一种名为SSA的抗炎药，改善T2D患者的血糖控制。建议在T2D和DHF患者中进行的安慰剂对照双盲随机对照试验将检验这样一个假设，即水杨酸盐调节炎症通路导致改善左室舒张末期充盈压(由左室舒张功能的回声衍生指数决定)和改善患者的功能容量(由V02max决定)。B.关于建立临床研究技能发展核心(CRSDC)以培训心力衰竭临床研究人员的建议。CRSDC有三个主要目标：1.支持两名CRSDC学者每年参加为期两年的科学硕士学位课程，接受临床心力衰竭研究方面的培训。学者将通过课程作业、研讨会和与参与临床研究的多学科教师/导师小组的一对一接触来获得临床研究技能。2.制定心力衰竭临床研究的个体化指导方案。这将包括：a)完成有指导的临床HF研究项目；b)通过指导和指导促进学者的职业发展；c)准备并提交资助提案；以及d)评估学者、导师和CRSDC计划。3.实施专门针对HF的课程：a)每周简历研讨会；b)每季度HF讲座系列；c)每年HF专题讨论会；d)HF客座教授职位；e)可选的外部轮换。 公共卫生相关性：相关性(参见说明)：建议作为地区临床中心(RCC)参与NHLBI赞助的心力衰竭网络，该网络旨在提供一个计划，该计划将继续提供支持，以开发、协调和进行多个协作性随机临床试验(RCT)，以改善心力衰竭的结果。RCCS将在协作制定该网络的科学议程方面提供科学领导。

DESCRIPTION (provided by applicant): 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 heat 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. PUBLIC HEALTH RELEVANCE: RELEVANCE (See instructions): 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.