Heart Failure Clinical Research Network Regional Clinical Center (U10)

复合材料 项目总结 这项提案的首要目标是杜克大学医学中心区域临床 中心(Duke RCC)用于心力衰竭临床研究网络(HF Network)是为了提高 通过高影响力的以患者为中心的临床研究，护理心力衰竭患者。这一目标 将通过与高频网络所有组成部分的积极协作来实现，包括其他 RCC、数据协调中心(DCC)、相关核心实验室和NHLBI。的总目标是 心力衰竭网络旨在通过优化应用现有治疗方法来改善结果，评估 新疗法，并促进将新的基础科学发现应用于临床 调查。我们相信，杜克RCC非常有能力为成功的 这些目标的实现基于开发原创、创新、 解决心脏临床重要研究问题的高影响力临床研究方案 失败，并提出了一种针对急性心力衰竭患者的新方案，队长研究 申请。杜克RCC已经证明有能力招募科学上合适的和符合种族和 将不同种族的患者纳入心力衰竭网络临床方案，并提供 准确、完整、及时、合规。正如本提案中详细说明的那样，杜克RCC有 一支专注且经验丰富的研究团队，结合了广泛的临床、研究和 这些操作技能将共同为HF的总体成功做出重大贡献 网络。杜克RCC我们将参与制定研究方案、统计 方法，以及数据收集和协议实施的计划。我们将在以下位置提供投入 从科学和可行性的角度适当地进行研究设计。我们将实施 经协议审查委员会(PRC)和NHLBI批准的每个网络范围的协议；遵守 与指导委员会批准的研究政策和质量保证措施，并同意 数据和安全监测委员会(DSMB)对这项研究的监督。最后，杜克RCC将 开发临床研究技能开发核心以培训后代心力衰竭 研究人员。 相关性(请参阅实例)： 这项建议为杜克地区临床中心的NHLBI心力衰竭临床研究 Network将开发和实施高影响、科学严谨的随机临床试验 旨在改善心力衰竭患者的健康。拟议研究的结果 将对数百万心力衰竭患者产生直接的临床影响。

Composite PROJECT SUMMARY 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, the 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 instnjctions): 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.