Mid Atlantic Heart Failure Network

描述（由申请人提供）：这是宾夕法尼亚大学医学院作为区域临床中心（RCC）和临床研究技能发展核心参与心力衰竭临床研究网络（HF-CRN）的申请。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。作为一个综合，我们的站点跟踪了6000多名人口统计学上不同的心力衰竭（HF）患者，每年有1900多名新转诊，18000次门诊和2900例心力衰竭住院。现有心衰患者群体的规模和多样性以及我们的站点所提供的转诊基础，将使我们的RCC能够识别和招募几乎任何类型的心衰临床研究的患者。因此，我们提出了一项新的临床试验，研究重组胰高血糖素样肽（GLP-1）在严重收缩期心力衰竭患者中的治疗效果。认识到最近的研究表明30%的死亡率或再住院率以及多次住院干预的失败，我们的研究将住院登记的后勤优势与住院后干预的需要结合起来。GLP-1的治疗前景是基于衰竭心脏受到生物能量挑战的假设，并且数据表明糖尿病患者和非糖尿病患者合并严重收缩期心力衰竭的心肌胰岛素抵抗都很高。已发表的小型研究表明，GLP-1可改善慢性心力衰竭、急性心肌梗死和冠状动脉旁路移植术相关收缩功能障碍患者的心肌功能和预后，进一步支持GLP-1的安全性和潜在疗效。这些试验都是由宾夕法尼亚大学医学主席理查德·香农博士领导的，他将担任这项申请的顾问。在360名随机患者中，该研究将检查GLP-1对死亡或复发住院的主要终点和几个次要终点的影响，包括通过多巴酚丁胺应激超声心动图评估的心肌收缩储备、6分钟步行距离和生活质量。这项在高风险人群中GLP-1的新研究非常适合HF-CRN的组织和强度。相关性（见说明）：在美国，心力衰竭是导致死亡的主要原因，给公众健康和经济带来了沉重负担。心衰住院患者预后不良的风险特别大。通过评估有前景的临床干预措施，包括胰高血糖素样肽（GLP-1），本建议为NHLBI心力衰竭网络建立一个新的区域临床中心，将有助于改善心力衰竭患者的护理。

DESCRIPTION (provided by applicant): 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 clinica 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.