New England, New York and Quebec Regional Clinical Center

新英格兰、纽约和魁北克地区临床中心

• 批准号: 7475109
• 负责人: MARTIN M LEWINTER
• 金额: $ 31.12万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7475109
• 关键词: Advanced Glycosylation End Products; Agonist; Anti-Inflammatory Agents; Anti-inflammatory; Biological Markers; Biopsy; Blood; Blood Vessels; Cardiac Surgery procedures; Clinical; Clinical Research; Clinical Trials; Collagen; Commit; Defect; Diabetes Mellitus; Disease; Elements; Enrollment; Functional disorder; Goals; Healthcare; Heart; Heart failure; Human Resources; Hypertension; In Vitro; Inflammation; Inflammatory; Institution; Insulin Resistance; Massachusetts; Medical center; Metabolic; Methods; Myocardial; Myocardium; New England; New York; Non-Insulin-Dependent Diabetes Mellitus; Operative Surgical Procedures; Outcome; Oxidative Stress; Participant; Patients; Peroxisome Proliferator-Activated Receptors; Pharmaceutical Preparations; Population; Private Practice; Property; Quebec; Risk; Risk Factors; Skin; Staging; Thinking; Treatment Protocols; Universities; Vermont; abstracting; adiponectin; crosslink; diabetic cardiomyopathy; experience; follow-up; hospital bed; improved; randomized placebo controlled trial; rural area; tertiary care

DESCRIPTION (provided by applicant): This is an application for designation as a Regional Clinical Center (RCC) of the Heart Failure (HF) Clinical Research Network. The participants are a diverse group of institutions in Northern New England, New York and Quebec, including the University of Vermont/Fletcher Allen Health Care (the sponsoring institution), Albany/St. Peter's Medical Centers, Catholic Medical Center, Dartmouth-Hitchcock Medical Center, McGill Medical Center and Univ. of Massachusetts Medical Center. The proposed RCC has a tertiary care catchment population over 6,000,000 and over 3,500 hospital beds. In 2004, over 2300 new patients with HF were seen, and over 180 follow-up patients with HF were seen weekly. The RCC also includes cardiologists in private practice in Vermont and New York who are committed to enrolling patients from rural areas who rarely participate in clinical trials. Key personnel have extensive experience in planning and management of multi-center trials and local PIs at each institution are experienced participants. Various collaborative activities are planned to maintain a vibrant regional network. The two proposed projects for the RCC share a. common theme, type 2 diabetes mellitus (DM) as a risk factor for and mechanism of HF. Project #1 is a placebo-controlled, randomized trial of a thiazalodinedione to treat diastolic dysfunction (DD), a common and early manifestation of diabetic cardiomyopathy. Secondary outcomes are systolic dysfunction and changes in blood levels of pro-inflammatory and pro-fibrotic biomarkers. Project #2 employs methods we have developed to study "skinned" strips of myocardium obtained during cardiac surgery as well as from endstage, explanted hearts. By using surgical biopsies, we can examine non-end stage disease states that can cause HF and delineate disease-specific elements of pathophysiology and drug effects. We will use these methods to determine the in vitro, disease-specific effects of the drug Alagebrium, a breaker of advanced glycation end-product (AGE) associated collagen cross-links, on passive stiffness in patients with DM, hypertension (HTN) and DM + HTN. AGEs are thought to cause increased myocardial and vascular stiffness in these patients. Results will be correlated with pre-operative DD and assessment of AGEs by immuno electronmicroscopy. The studies we propose for our RCC have potential to reduce the risk of HF in patients with DM. Biopsy studies will improve understanding of pathophysiology and drug effects and mechanisms. (End of Abstract)

描述（由申请人提供）： 这是指定为心力衰竭（HF）临床研究网络的区域临床中心（RCC）的应用。参与者是新英格兰北部，纽约和魁北克的各种各样的机构，包括佛蒙特大学/弗莱彻·艾伦卫生保健（赞助机构），奥尔巴尼/街。彼得医疗中心，天主教医疗中心，达特茅斯 - 希区柯克医疗中心，麦吉尔医疗中心和大学。马萨诸塞州医疗中心。拟议的RCC的三级护理集水集人口超过6,000,000，并有3500多个医院病床。在2004年，有2300多名HF患者，每周可见超过180名HF患者。 RCC还包括佛蒙特州和纽约私人执业的心脏病专家，他们致力于招募很少参加临床试验的农村地区的患者。关键人员在多中心试验的计划和管理方面具有丰富的经验，每个机构的本地PI是有经验的参与者。计划进行各种协作活动，以维持充满活力的区域网络。 RCC的两个项目共享a。共同主题，2型糖尿病（DM）是HF的危险因素和机制。项目＃1是一个安慰剂对照的，随机试验，用于治疗舒张期功能障碍（DD），一个常见和 糖尿病心肌病的早期表现。次要结果是收缩功能障碍以及促炎和促纤维化生物标志物的血液水平的变化。项目＃2采用了我们开发的方法来研究心脏手术期间获得的心肌的“剥皮”条，从终点播放了心脏。通过使用手术活检，我们可以检查可能导致HF和描述病理生理学和药物作用的疾病特异性元素的非结局阶段疾病状态。我们将使用这些方法来确定药物的体外，疾病特异性作用，Alagebrium是晚期糖基化终产物（年龄）相关胶原蛋白交叉链接的破裂，对DM，高血压（HTN）和DM + HTN患者的被动僵硬度。人们认为年龄会导致这些患者的心肌和血管僵硬增加。结果将与术前DD和通过免疫电子显微镜对年龄的评估相关。我们针对RCC提出的研究有可能降低DM患者HF的风险。活检研究将提高对病理生理学和药物作用和机制的理解。 （抽象的结尾）