Mayo Heart Failure Regional Clinical Center

梅奥心力衰竭区域临床中心

基本信息

批准号：
8196073
负责人：
Margaret M Redfield
金额：
$ 52.04万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-01-01 至 2018-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8196073
关键词：
Academic Training Acute Address Admission activity Ancillary Study Biological Brain natriuretic peptide Cardiovascular system Cessation of life Chronic Clinic Clinical Clinical Research Clinical Sciences Complex Data Development Diagnosis Educational Activities Enrollment Evaluation Failure Functional disorder Funding Future Goals Heart failure Heterogeneity Hospitalization Hospitals Hour Instruction Intervention Kidney Laboratory Research Lead Length of Stay Medicare Mentorship Morbidity - disease rate Outcome Participant Patients Physicians Physiological Placebos Prevention Principal Investigator Proteins Protocols documentation Public Health Publishing Randomized Randomized Clinical Trials Research Research Infrastructure Research Personnel Research Support Research Training Resources Safety Scientist Severities Site Structure Subgroup Syndrome Testing Therapeutic Therapeutic Intervention Therapeutic Uses Time Training Programs Translational Research Treatment Efficacy United States National Institutes of Health base bench to bedside career development data registry design double-blind placebo controlled trial evaluation/testing improved innovation member mortality novel novel therapeutic intervention novel therapeutics phase 3 study prevent programs skills subcutaneous success tool

项目摘要

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.

描述（由申请人提供）：本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网络 (HFCRN) 中的临床研究技能开发核心 (SDC) 站点。在 HFCRN 的第一个资助期，梅奥是 RCC 和 SDC 站点。 Mayo RCC 研究人员设计并担任两项 HFCRN 试验（RELAX 和 ROSE）和三项辅助研究的首席研究员 (PI)。我们主导九个 HFCRN 站点的注册。我们提出的方案是 POSE（出院后优化策略评估）；一项随机、双盲、安慰剂对照试验，在因急性心力衰竭综合征 (AHFS) 入院的患者中，在出院时将 BNP 皮下 (SQ) 给药添加到标准治疗中，并持续 30 天。假设：与安慰剂相比，根据综合 HF 稳定性评分评估，SQ BNP 治疗与出院后 60 天更高的临床稳定性相关。 POSE 的长期目标是为未来充分有力的 III 期研究提供理论依据，以测试该策略对心力衰竭再入院的影响。 POSE 是一项小型概念验证研究，它在新型 AHFS 治疗窗口测试创新治疗策略，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作用，针对适当的 AHFS 亚组，并使用反映临床稳定性的新颖、高度定量的复合终点。最后，我们记录了梅奥 HFCRN 临床研究技能开发核心 (SDC) 在第一轮资助中取得的成功，并概述了我们在梅奥 SDC 应用程序中培训学术性 HF 医师科学家的持续战略。相关性（参见说明）：本提案代表现有梅奥区域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，即通过随机临床试验测试干预措施来改善心力衰竭的治疗心力衰竭及其发病率的管理。