Heart Failure Clinical Trials Network

在这项提案中，埃默里大学心脏病学分部寻求成为一个区域临床中心， (RCC)在NHLBI的心力衰竭（HF）临床研究网络中， 有兴趣产生和促进以证据为基础的HF实践计划。在此，我们描述我们的HF 以及相关项目、合作者和相关临床和研究项目及机构，我们的 研究和其他成就，以及我们的教师和关键人员;我们还提供我们的证据 HF临床试验的机构和个人专业知识，以及获得相关 患者人群，包括女性和少数民族，HF患者的数量非常大，以及 在拟议的埃默里RCC的多学科合作。我们认为，埃默里大学的基础设施和 调查人员有能力实现网络的主要和次要目标。如果被选为 RCC，埃默里团队将努力工作，以实现网络的各种目标。我们还寻求 制定并实施临床研究技能发展核心，以协助新研究者 发展他们的研究技能，从而利用网络提供的丰富环境， 建立在心血管医学中专注于HF的训练有素的临床研究人员的核心之上。作为 表明我们的能力，构思，设计和进行临床试验，我们还提出了一个随机， 安慰剂对照临床试验（急性HF中一氧化氮诱导的血管舒张评价- NOVEL-HF）， 评价肼苯哒嗪与硝酸异山梨酯（H-ISDN）口服联合治疗 因收缩功能障碍导致的HF，因急性失代偿性HF（AHDF）入院。这种疗法与 基于观察数据，血流动力学获益可改善ADHF的结局。埃默里 大学有一个长期的承诺，多样性和人口在亚特兰大市的混合提供了一个 丰富的环境来研究不同患者群体之间治疗的相似性和差异。我们 因此，建议进行一项临床试验，以评估当今HF医学面临的一个关键临床问题，即H- ISDN在ADHF中的益处和作用机制，以及黑人与非黑人HF患者的结局。

In this proposal, the Division of Cardiology at Emory University seeks to become a Regional Clinical Center (RCC) within NHLBI's Heart Failure (HF) Clinical Research Network, a network of centers with active HF programs interested in generating and promoting evidence-based HF practice. Herein, we describe our HF and related programs, collaborators, and related clinical and research programs and institutions, our research and other accomplishments, and our faculty and key personnel; we also provide evidence of our institutional and individual expertise in clinical trials in HF, as well as documentation of access to relevant patient populations including women and minorities, extraordinary volume of HF patients, and multidisciplinary collaboration in the proposed Emory RCC. We believe that the Emory University infrastructure and investigators are well-equipped to achieve the primary and secondary goals of the Network. If chosen as a RCC, the Emory team will work diligently to achieve the various aims for the Network. We also seek to develop and implement a Clinical Research Skills Development Core to assist new investigators in developing their research skills, thus taking advantage of the rich environment presented by the Network and build upon the core of well trained clinical researchers within cardiovascular medicine focused on HF. As an indication of our ability to conceive, design, and conduct clinical trials, we also propose a randomized, placebo-controlled clinical trial (Nitric Oxide induced Vasodilation Evaluation in acute HF - NOVEL-HF) to evaluate the efficacy of the oral combination of hydralazine plus isosorbide dinitrate (H-ISDN) in patients with HF due to systolic dysfunction admitted with acute decompensated HF (AHDF). This therapy is associated with hemodynamic benefits that could improve outcomes in ADHF based on observational data. Emory University has a longstanding commitment to diversity and the population mix in the city of Atlanta offers a rich environment to study the similarities and differences in treatment among diverse patient groups. We therefore propose a clinical trial to assess a key clinical question facing HF medicine today, i.e. the role of H- ISDN in ADHF, its benefits and mechanisms of action, and outcomes in black versus non-black HF patients.