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

SALsalate 可改善 T2dm-DHF 患者的运动耐受性和 LVDD（SALIENT-DHF 试验）

基本信息

批准号：
8588994
负责人：
Victor G. Davila-Roman
金额：
$ 50.24万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-01-01 至 2018-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8588994
关键词：
Accounting Activities of Daily Living Acute Anaerobic Threshold Anti-Inflammatory Agents Anti-inflammatory Applications Grants Blood Vessels Cardiology Cardiomyopathies Cardiopulmonary Cardiovascular system Cessation of life Chronic Cities Clinical Clinical Investigator Clinical Research Clinical Trials Collagen Degenerative polyarthritis Development Diabetes Mellitus Diastolic heart failure Digitalis preparation Double-Blind Method Echocardiography Educational Curriculum Enrollment Exercise Exercise Tolerance Exercise stress test FDA approved Faculty Fibrosis Functional disorder Gender Generic Drugs Heart Hypertrophy Heart failure Hospitalization Individual Inflammation Instruction Insulin Resistance Investigation Kansas Lead Leadership Left Master of Science Measures Mediating Mentors Missouri Morbidity - disease rate Myocardial N(6)-carboxymethyllysine National Heart, Lung, and Blood Institute Non-Insulin-Dependent Diabetes Mellitus Outcome Oxidative Stress Pathway interactions Patients Peroxidases Pharmaceutical Preparations Phase Placebo Control Placebos Quality of life Questionnaires Randomized Randomized Clinical Trials Recruitment Activity Relaxation Research Research Design Research Project Grants Rotation Series Serum Markers Testing Time Training Universities Ventricular Visit Walking Washington aged brachial artery career clinical research site glycemic control hazard high risk improved improved functioning indexing inflammatory modulation lectures mortality multidisciplinary pressure procollagen Type III-N-terminal peptide procollagen type I carboxy terminal peptide programs prospective racial and ethnic response salicylsalicylic acid skills socioeconomics symposium treatment trial trial comparing

项目摘要

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.

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)，由遍布密苏里州的 5 个临床中心组成。拟议的 RCC 将能够招募来自不同社会经济、性别、民族和种族背景，用于急性和慢性试验收缩性心力衰竭 (SHF) 患者的心力衰竭试验和舒张性心力衰竭（DHF）。该应用程序的两个附加组件是： A. 针对 2 型糖尿病 (T2D) 和 DHF，使用双水杨酸 (SSA)，这是一种抗炎剂，可改善 T2D 的血糖控制。拟议的针对 T2D 和 DHF 患者的安慰剂对照双盲随机对照试验将检验这一假设通过水杨酸调节炎症途径可改善左心室舒张末期充盈压力（由回声衍生的左室舒张功能指数确定）并改善患者功能容量（由 V02max 确定）。 B. 关于建立临床研究技能开发核心 (CRSDC) 来培训心力衰竭临床研究人员的提案。 CRSDC 的三大目标： 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心力衰竭研究。学者们将获得临床通过课程作业、研讨会以及与多学科小组的一对一接触来提高研究技能参与临床研究的教师/导师。 2. 制定临床心力衰竭的个性化指导计划研究。这将包括： a) 完成指导性临床心力衰竭研究项目； b) 提拔学者通过辅导和指导实现职业发展； c) 准备并提交资助提案；和 d) 评估学者、导师和 CRSDC 项目。 3. 实施 HF 特定课程：a) 每周简历研讨会； b) 季度高频系列讲座； c) 每年一次的高频研讨会； d) HF客座教授；和 e) 可选的外部旋转。