Mayo Heart Failure Regional Clinical Center

该提案代表梅奥诊所申请成为区域临床中心(RCC) 和心力衰竭临床研究技能发展核心(SDC)的网站 研究网络(HFCRN)。在HFCRN的第一个资助期，Mayo是RCC和SDC网站。这个 梅奥RCC调查员设计并担任了两个HFCRN试验的首席调查员(PI) (放松和玫瑰)和三项辅助研究。我们在九个HFCRN网站上领先注册。我们的 建议的协议是POST(住院后优化策略评估)；一个随机的、双倍的 在标准治疗的基础上加用BNP的盲法、安慰剂对照试验 对于因急性心力衰竭综合征(AHFS)入院的患者，出院并持续30天。 假设：与安慰剂相比，SQ BNP治疗将与更好的临床稳定性相关。 出院后60天用综合心力衰竭稳定性评分进行评估。摆姿势的长期目标是 为未来进行动力充足的第三阶段研究提供理论基础，以测试该策略对心衰的影响 重新入院。POSE是一项小型概念验证研究，旨在测试一种创新的治疗策略 新的AHFS治疗窗口将AHFS治疗干预的时间进程延长到 脆弱的出院后时期，促进临床进一步稳定。姿势瞄准适当的AHF 基于AHFS的病理生理学和拟议的治疗性和 使用一种新的、高度定量的复合终点，反映了临床稳定性。最后，我们记录了 梅奥HFCRN临床研究技能开发核心(SDC)的首个成功 资金循环，并概述我们在梅奥培训学术心衰内科科学家的持续战略 SDC应用程序。 相关性(请参阅说明)： 这份提案代表了现有的梅奥区域临床中心和梅奥的申请 以临床研究技能发展为核心参与心力衰竭临床研究 网络。梅奥的参与将推进该网络的目标，即改善心力衰竭的治疗 通过随机临床试验测试有助于控制心力衰竭及其发病率的干预措施。

This proposal represents an application by the Mayo Clinic to be a REGIONAL CLINICAL CENTER (RCC) and a site for a CLINICAL RESEARCH SKILLS DEVELOPMENT CORE (SDC) in the Heart Failure Clinical Research Network (HFCRN). Mayo was a RCC and SDC site in the first funding period of the HFCRN. The Mayo RCC investigators designed and as serve as the principal investigator (PI) on two HFCRN trials (RELAX and ROSE) and three ancillary studies. We lead enrollment across the nine HFCRN sites. Our proposed protocol is POSE (Post-hospitalization Optimization Strategies Evaluation); a randomized, double- blind, placebo-controlled trial of subcutaneous (SQ) administration of BNP added to standard therapy at hospital dismissal and continued for 30 days in patients admitted for acute heart failure syndrome (AHFS). Hypothesis: As compared to placebo, therapy with SQ BNP will be associated with greater clinical stability at 60 days post discharge as assessed by a composite HF stability score. The long-term goal of POSE is to provide the rationale for a future adequately powered phase III study to test the impact of this strategy on HF readmissions. POSE is a small proof-of-concept study which tests a innovative therapeutic strategy at a novel AHFS therapeutic window extending the time course of therapeutic interventions in AHFS into the vulnerable post-discharge period to promote further clinical stabilization. POSE targets the appropriate AHFS subgroup based on the pathophysiology of AHFS and the biological actions of the proposed therapeutic and uses a novel, highly quantitative composite endpoint reflecting clinical stability. Finally, we document the successes of the MAYO HFCRN CLINICAL RESEARCH SKILLS DEVELOPMENT CORE (SDC) in the first cycle of funding and outline our continued strategy to train academic HF physician scientists in our Mayo SDC application. RELEVANCE (See instructions): This proposal represents an application by the existing MAYO REGIONAL CLINICAL CENTER and MAYO CLINICAL RESEARCH SKILLS DEVELOPMENT CORE to participate in the Heart Failure Clinical Research Network. Mayo's participation will advance the goal of the Network which is to improve the treatment of HF by testing, through randomized clinical trials, interventions aiding in the management of HF and its morbidity.