Mayo Heart Failure Regional Clinical Center

描述(由申请人提供)：本提案代表梅奥诊所申请成为心力衰竭临床研究网络(HFCRN)中的地区临床中心(RCC)和临床研究技能发展核心(SDC)的地点。在HFCRN的第一个资助期，Mayo是RCC和SDC网站。梅奥RCC的研究人员设计并担任了两项HFCRN试验(RELAX和ROSE)和三项辅助研究的首席研究员(PI)。我们在九个HFCRN网站上领先注册。我们建议的方案是POST(住院后优化策略评估)；这是一项随机、双盲、安慰剂对照试验，将BNP皮下注射(SQ)添加到出院时的标准治疗中，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，根据综合心力衰竭稳定性评分，SQ BNP治疗与出院后60天的临床稳定性更好相关。POSE的长期目标是为未来的动力充足的第三阶段研究提供理论基础，以测试这一策略对心衰再入院的影响。POSE是一项小型概念验证研究，它在一个新的AHFS治疗窗口测试创新的治疗策略，将AHFS治疗干预的时间进程延长到脆弱的出院后时期，以促进进一步的临床稳定。POSE根据AHFS的病理生理学和拟议治疗的生物学行为针对适当的AHFS亚组，并使用反映临床稳定性的新的、高度定量的复合终点。最后，我们记录了Mayo HFCRN临床研究技能开发核心(SDC)在第一轮资助中的成功，并概述了我们在Mayo SDC应用中培训学术心衰内科科学家的持续战略。相关性(参见说明)：该提案代表现有的梅奥地区临床中心和梅奥临床研究技能开发核心申请加入心力衰竭临床研究网络。梅奥的参与将推进该网络的目标，即通过测试、通过随机临床试验、干预措施帮助改善心力衰竭的治疗 心力衰竭的处理及其发病率。

DESCRIPTION (provided by applicant): 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.