Mid Atlantic Heart Failure Network

这是宾夕法尼亚大学医学院申请参加心脏 失败临床研究网络（HF-CRN）作为区域临床中心（RCC）和临床研究中心 技能发展核心。我们的中大西洋RCC包括约翰霍普金斯大学和兰开斯特心脏 组作为一个复合体，我们的研究中心跟踪了6，000多名患者的人口统计学多样化人群 心力衰竭（HF）患者，新转诊超过1，900例，门诊就诊18，000例，HF 2，900例 每年住院。现有HF患者人群和转诊基础的规模和多样性 我们的研究中心提供的服务将使我们的RCC能够识别和招募几乎任何类型的HF临床患者 调查研究。有了这个应用程序，我们提出了一个新的临床试验检查的治疗效果， 重组胰高血糖素样肽（GLP-1）治疗重度收缩期HF患者。认识到最近 研究表明，30%的死亡率或再住院率以及多次住院治疗失败率 干预措施，我们的研究夫妇的后勤优势，在医院登记的需要后， 住院干预。GLP-1的治疗前景是基于以下假设： 心脏受到生物能量的挑战，数据表明心肌胰岛素抵抗在两者中都很高， 患有严重收缩期HF的糖尿病患者和非糖尿病患者。小型已发表研究表明GLP-1 改善慢性心肌梗死相关性收缩功能障碍患者的心肌性能和预后 心力衰竭、急性心肌梗死和冠状动脉旁路移植术进一步支持了安全性， GLP-1的潜在功效。每一项试验都是由医学委员会主席理查德·香农博士领导的 他将担任这项申请的顾问。在360例随机化患者中， 将检查GLP-1对死亡或复发住院的主要终点的影响， 次要终点包括通过多巴酚丁胺负荷评估的心肌收缩储备 超声心动图，6分钟步行距离，生活质量。这项在高风险人群中进行的GLP-1新研究 非常适合HF-CRN的组织和实力。 相关性（参见说明）： 心力衰竭是美国死亡率的主要原因，这对美国的公共卫生和财政造成了重大影响。 负担HF住院患者预后不良的风险特别高。通过评估有前途的 临床干预措施，包括胰高血糖素样肽（GLP-1），本建议建立一个新的区域 NHLBI心力衰竭网络的临床中心将有助于改善心力衰竭患者的护理。

This is an application from the University of Pennsylvania School of Medicine to participate in the Heart Failure Clinical Research Network (HF-CRN) as a regional clinical center (RCC) and as a Clinical Research Skills Development Core. Our Mid-Atlantic RCC includes Johns Hopkins University and the Lancaster Heart Group. As a composite, our sites follow a demographically diverse population of more than 6,000 patients with heart failure (HF), with more than 1,900 new referrals, 18,000 outpatient visits and 2,900 HF hospitalizations annually. The size and diversity of the existing HF patient population and referral base served by our sites will enable our RCC to identify and enroll patients in virtually any type of HF clinical research study. With this application, we propose a novel clinical trial examining the therapeutic efficacy of recombinant glucagon-like peptide (GLP-1) in patients with severe systolic HF. Recognizing that recent studies demonstrate a 30% rate of death or re-hospitalization and the failure of multiple in-hospital interventions, our study couples the logistical advantages of in-hospital enrollment with the need for a post- hospitalization intervention. The therapeutic promise of GLP-1 is based on the hypothesis that the failing heart is challenged bioenergetically and date indicating that myocardial insulin resistance is high among both diabetics and non-diabetics with severe systolic HF. Small published studies demonstrating that GLP-1 improves myocardial performance and outcomes in patients with systolic dysfunction associated with chronic heart failure, acute myocardial infarction and coronary bypass grafting further support the safety and potential efficacy of GLP-1. Each of these trials was led by Dr. Richard Shannon, the Chairman of Medicine at Penn, who will serve as a consultant for this application. In 360 randomized patients, the proposed study will examine the effect of GLP-1 on the primary endpoint of death or recurrent hospitalization and several secondary endpoints including myocardial contractile reserve assessed via dobutamine stress echocardiography, 6-minute walk distance, quality of life. This novel study of GLP-1 in a high risk population is well-suited to the organization and strength of the HF-CRN. RELEVANCE (See instructions): Heart failure is a leading cause of mortality in the U.S. that imposes a major public health and financial burden. Patients hospitalized with HF are at particular risk for poor outcomes. By evaluating promising clinical interventions, including glucagon-like peptide (GLP-1), this proposal to establish a new regional clinical center for the NHLBI Heart Failure Network will help improve the care of patients with heart failure.