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

描述（由申请人提供）：根据RFA-HL-12-001，本申请旨在建立华盛顿大学心力衰竭区域临床中心（HF-RCC），该中心由位于密苏里州的5个临床站点组成。拟议的RCC将能够从广泛的社会经济、性别、民族和种族背景中招募患者，用于收缩性（SHF）和舒张性热衰竭（DHF）患者的急性和慢性心力衰竭试验。该申请的另外两个组成部分是：a .建议在2型糖尿病（T2D）和DHF患者中进行早期随机临床试验（RCT），使用水杨酸盐（SSA），一种改善T2D血糖控制的抗炎剂。这项针对T2D和DHF患者的安慰剂对照双盲随机对照试验将验证水杨酸盐调节炎症通路可改善左心室舒张末期充盈压力（由左室舒张功能的回声衍生指数决定）和改善患者功能容量（由V02max决定）的假设。B.建议建立临床研究技能发展核心（CRSDC）以培训心衰临床研究者。CRSDC有三个主要目标：1。每年资助两名CRSDC学者参加为期两年的科学硕士学位课程，接受临床心衰研究培训。学者将通过课程学习、研讨会以及与参与临床研究的多学科教师/导师进行一对一的接触来获得临床研究技能。2. 在临床心衰研究中制定个性化的指导方案。这将包括：a)完成一个有指导的心衰临床研究项目；B)通过指导和指导促进学者的职业发展；C)准备并提交拨款提案；d)评估学者、导师和CRSDC项目。3. 实施针对高频病毒的课程：a)每周简历研讨会；b)季度HF系列讲座；c) HF年度研讨会；d) HF客座教授；e)可选的外部旋转。

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.