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

描述（由申请人提供）：本申请是对RFA-HL-12-001的回应，旨在建立一个华盛顿大学心力衰竭区域临床中心（HF-RCC），由位于密苏里州的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、种族和种族背景中招募患者，用于收缩期（SHF）和舒张期心力衰竭（DHF）患者的急性和慢性心力衰竭试验。该应用程序的两个附加组件是：建议在2型糖尿病（T2 D）和DHF患者中进行早期随机临床试验（RCT），使用双水杨酯（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将检验以下假设：双水杨酸盐对炎症通路的调节可改善左心室舒张末期充盈压（通过超声心动图导出的LV舒张功能指数确定）和改善患者功能容量（通过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学者参加为期2年的理学硕士学位课程，接受临床HF研究培训。学者将通过课程，研讨会和一对一接触参与临床研究的教师/导师的多学科小组获得临床研究技能。2.在临床心力衰竭研究中发展个体化指导计划。这将包括：a）完成指导的临床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HF特定课程：a）每周CV研讨会; B）季度HF讲座系列; c）年度HF研讨会; d）HF访问教授;和e）可选的外部轮换。 公共卫生相关性：相关性（参见说明）：建议作为区域临床中心（RCC）参与NHLBI申办的心力衰竭网络，该网络旨在提供一个项目，该项目将继续为开发、协调和开展多项合作随机临床试验（RCT）提供支持，以改善HF结局。区域协调中心将在协作制定网络科学议程方面发挥科学领导作用。

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.