Heart Failure Clinical Research Network Regional Clinical Center (U10)

描述（由申请人提供）：本提案针对心力衰竭临床研究网络（HF网络）的杜克大学医学中心区域临床中心（杜克RCC）的首要目标是通过高影响力的以患者为导向的临床研究改善心力衰竭患者的护理。这一目标将通过与高频网络的所有组成部分积极合作来实现，包括其他RCC、数据协调中心（DCC）、相关核心实验室和NHLBI。HF网络的总体目标是通过现有疗法的最佳应用、新型疗法的评价以及促进新兴基础科学发现在临床研究中的应用来改善结局。我们相信，杜克RCC非常有能力为成功实现这些目标做出贡献，这是基于开发原创性、创新性、高影响力的临床研究方案的良好记录，这些方案解决了心力衰竭中的临床重要研究问题，并在本申请中提出了一种针对急性心力衰竭患者的新方案，即CAPTAIN研究。经证明，杜克RCC有能力招募科学上适当的、种族和人种多样化的患者人群进入HF网络临床方案，并提供准确、完整、及时且符合法规的数据。如本提案所述，杜克大学RCC拥有一支专业且经验丰富的研究人员团队，结合了广泛的临床、研究和操作技能，这些技能将共同成为 为HF网络的整体成功做出了重大贡献。我们将参与杜克RCC研究方案、统计方法以及数据收集和方案实施计划的制定。我们将从科学和可行性的角度为研究设计提供适当的输入。我们将实施方案审查委员会（PRC）和NHLBI批准的每个网络范围的方案;遵守指导委员会批准的研究政策和质量保证措施，并同意由数据和安全性监查委员会（DSMB）监督研究。最后，杜克RCC将开发一个临床研究技能开发核心，以培训未来几代心力衰竭研究人员。 相关性（参见说明）：NHLBI心力衰竭临床研究网络的杜克区域临床中心的这一提案将开发和实施高影响力、科学严谨的随机临床试验，旨在改善心力衰竭患者的健康状况。这项研究的结果将对数百万心力衰竭患者产生直接的临床意义。

DESCRIPTION (provided by applicant): The overriding objective of this proposal for the Duke University Medical Center Regional Clinical Center (Duke RCC) for the Heart Failure Clinical Research Network (HF Network) is to improve the care of patients with heart failure through high-impact patient-oriented clinical research. This objective will be achieved through active collaboration with all components of the HF Network, including other RCCs, the Data Coordinating Center (DCC), associated core labs, and the NHLBI. The overall goal of the HF network is to improve outcomes through optimal application of existing therapies, evaluation of novel therapies, and to facilitate application of emerging basic science discoveries into clinical investigations. We believe the Duke RCC is highly capable of contributing to the successful achievement of these objectives based on a demonstrated record of developing original, innovative, high impact clinical research protocols addressing clinically important research questions in heart failure, and propose a novel protocol targeting acute heart failure patients, th CAPTAIN study, in this application. The Duke RCC has proven ability to recruit scientifically appropriate and ethnically and racially diverse populations of patients into HF Network clinical protocols and provide data that is accurate, complete, timely, and regulatory compliant. As detailed in this proposal, the Duke RCC has a dedicated and experienced team of investigators, combining a broad array of clinical, research, and operational skills that collectively will make a major contribution to the overall success of the HF Network. The Duke RCC we will participate in the development of research protocols, statistical methods, and plans for data collection and protocol implementation. We will provide input where appropriate into study design from both a scientific and a feasibility standpoint. We will implement each network-wide protocol approved by the protocol review committee (PRC) and the NHLBI; comply with study policies and quality assurance measures approved by the Steering Committee, and agree to oversight of the study by a Data and Safety Monitoring Board (DSMB). Finally, the Duke RCC will develop a Clinical Research Skills Development Core to train future generations of heart failure researchers. RELEVANCE (See instructions): This proposal for the Duke Regional Clinical Center of the NHLBI Heart Failure Clinical Research Network will develop and implement high impact, scientifically rigorous randomized clinical trials designed to improve the health of persons with heart failure. The results of the proposed research will have immediate clinical implications for millions of patients with heart failure.