Mayo Heart Failure Regional Clinical Center

梅奥心力衰竭区域临床中心

• 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
• 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

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）：该提案代表了马约诊所申请成为心力衰竭临床研究网络（HFCRN）中的区域临床中心（RCC）和临床研究技能开发核心（SDC）中心。马约是HFCRN第一个供资期的RCC和SDC站点。马约RCC研究人员设计并担任两项HFCRN试验（RELAX和ROSE）和三项辅助研究的主要研究者（PI）。我们在九个HFCRN研究中心负责招募。我们提出的方案是POSE（住院后优化策略评估）;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，SQ BNP治疗与出院后60天的临床稳定性更高相关（通过复合HF稳定性评分评估）。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再入院的影响。POSE是一项小型概念验证研究，在新的AHFS治疗窗口测试创新的治疗策略，将AHFS治疗干预的时间过程延长到出院后的脆弱时期，以促进进一步的临床稳定。POSE基于AHFS的病理生理学和拟定治疗的生物学作用靶向适当的AHFS亚组，并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，并概述了我们在马约SDC应用中培训学术HF医生科学家的持续战略。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开发核心参与心力衰竭临床研究网络的申请。马约的参与将推进该网络的目标，即通过随机临床试验，通过测试干预措施来改善HF的治疗， HF的管理及其发病率。