Mayo Heart Failure Regional Clinical Center

本提案代表马约诊所申请成为区域临床中心（RCC） 和心力衰竭临床研究技能开发核心（SDC）的网站 研究网络（HFCRN）。马约是HFCRN第一个供资期的RCC和SDC站点。的 马约RCC研究者设计并担任两项HFCRN试验的主要研究者（PI） （RELAX和ROSE）和三项辅助研究。我们在九个HFCRN研究中心负责招募。我们 建议的协议是POSE（住院后优化策略评估）;一个随机的，双 一项在标准治疗基础上添加BNP皮下（SQ）给药的盲态、安慰剂对照试验， 出院，并在因急性心力衰竭综合征（AHFS）入院的患者中持续30天。 假设：与安慰剂相比，SQ BNP治疗将与更高的临床稳定性相关， 出院后60天，通过复合HF稳定性评分进行评估。POSE的长期目标是 为未来充分把握度的III期研究提供依据，以测试该策略对HF的影响 再入院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中治疗干预的时间过程延长到 脆弱的出院后时期，以促进进一步的临床稳定。POSE针对适当的AHFS 基于AHFS的病理生理学和所提出的治疗和 使用反映临床稳定性的新型、高度定量复合终点。最后，我们记录了 马约HFCRN临床研究技能开发核心（SDC）在第一次 资助周期，并概述我们在马约培训学术HF医生科学家的持续战略 SDC应用程序。 相关性（参见说明）： 本提案代表了现有马约区域临床中心和马约 临床研究技能发展核心参与心力衰竭临床研究 网络马约的参与将推动该网络的目标，即改善HF的治疗 通过随机临床试验测试有助于管理HF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.