Mid Atlantic Heart Failure Network

大西洋中部心力衰竭网络

• 批准号: 8198078
• 负责人: THOMAS P. CAPPOLA
• 金额: $ 37.02万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 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/8198078
• 关键词: Accounting; Acute myocardial infarction; Adherence; Adult; Affect; Aftercare; Age; American; Basic Science; Biological Availability; Brain natriuretic peptide; Cardiomyopathies; Cessation of life; Chairperson; Chronic; Clinical; Clinical Research; Clinical Trials; Community Practice; Complement; Coronary; Coronary Artery Bypass; Couples; Death Rate; Development; Devices; Diagnosis; Dobutamine; Dobutamine Stress Echocardiography; Dose; Double-Blind Method; Drug Delivery Systems; Effectiveness; Employee Strikes; Enrollment; Faculty; Failure; Functional disorder; Future; Health Care Costs; Heart; Heart Valve Diseases; Heart failure; Hemoglobin; Hospitalization; Hospitals; Industry; Inpatients; Institution; Instruction; Insulin Resistance; Intervention; Laboratory Study; Lead; Leadership; Levosimendan; Life; Location; Measures; Medicine; Metabolic; Milrinone; Minnesota; Modeling; Multicenter Trials; Myocardial; National Heart, Lung, and Blood Institute; Outcome; Outcome Measure; Outpatients; Patient Care; Patients; Pennsylvania; Performance; Phase; Pilot Projects; Placebos; Plasma; Population; Population Heterogeneity; Prevalence; Principal Investigator; Productivity; Public Health; Publishing; Pump; Quality of life; Quality-of-Life Assessment; Randomized; Recombinants; Recurrence; Research; Research Design; Resources; Rest; Risk; Rural; Safety; Schedule; Series; Site; Site Visit; Structure; Suburban Population; Syndrome; Systolic heart failure; Testing; Therapeutic; Training; Translational Research; Treatment Efficacy; United States; Universities; Videoconferences; Videoconferencing; Visit; Walking; Weight; base; clinically relevant; design; diabetic; experience; glucagon-like peptide; glucagon-like peptide 1; high risk; improved; insight; medical schools; mortality; non-diabetic; novel; patient population; primary outcome; pro-brain natriuretic peptide (1-76); research study; response; secondary outcome; skills; standard care; subcutaneous; success; tolvaptan; web site

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.

描述(由申请人提供)：这是宾夕法尼亚大学医学院申请加入心力衰竭临床研究网络(HF-CRN)，作为地区临床中心(RCC)和临床研究技能发展核心。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小组。作为一个综合体，我们的网站遵循人口统计多样化的人口结构，超过6,000名心力衰竭(HF)患者，每年有1900多名新转诊患者、18,000名门诊患者和2,900名HF住院患者。我们网站服务的现有心力衰竭患者群体和转诊基础的规模和多样性将使我们的肾癌能够识别和招募几乎任何类型的心力衰竭临床研究的患者。通过这一应用，我们提出了一项新的临床试验，以检验重组胰高血糖素样肽(GLP-1)对严重收缩期心衰患者的治疗效果。认识到最近的研究表明30%的死亡率或再住院率以及多种医院干预措施的失败，我们的研究将医院内登记的后勤优势与住院后干预的必要性结合在一起。GLP-1的治疗前景是基于这样的假设，即衰竭的心脏受到生物能量的挑战，而且数据表明，在患有严重收缩心衰的糖尿病患者和非糖尿病患者中，心肌胰岛素抵抗都很高。已发表的小型研究表明，GLP-1改善了慢性心力衰竭、急性心肌梗死和冠状动脉旁路移植相关的收缩功能障碍患者的心肌功能和预后，进一步支持了GLP-1的安全性和潜在疗效。这些试验中的每一项都由宾夕法尼亚大学医学主席理查德·香农博士领导，他将担任这项申请的顾问。在360名随机患者中，拟议的研究将检查GLP-1对死亡或反复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负荷超声心动图、6分钟步行距离和生活质量评估的心肌收缩储备。这项在高危人群中对GLP-1进行的新研究非常适合于HF-CRN的组织和强度。相关性(参见说明)：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重大负担。因心力衰竭住院的患者预后不良的风险尤其大。通过评估前景看好的临床干预措施，包括胰升糖素样肽(GLP-1)，为NHLBI心力衰竭网络建立一个新的地区性临床中心的提议将有助于改善心力衰竭患者的护理。