Harvard Regional Clinical Center of the NHLBI Heart Failure Network

NHLBI 心力衰竭网络哈佛区域临床中心

• 批准号: 8198047
• 负责人: MICHAEL M GIVERTZ
• 金额: $ 49.87万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 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/8198047
• 关键词: Address; Admission activity; Ancillary Study; Basic Science; Cardiac; Cardiopulmonary; Caring; Cessation of life; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Consensus; Data; Databases; Development; Dilated Cardiomyopathy; Educational Curriculum; Enrollment; Exercise; Functional disorder; Funding; Future; General Hospitals; Genes; Hand; Health; Heart failure; Hemoglobin; Hospitalization; Hospitals; Individual; Instruction; Intravenous; Investigation; Iron; Iron-Regulatory Proteins; Kidney; Laboratories; Leadership; Left Ventricular Ejection Fraction; Life; Link; Massachusetts; Measures; Medical center; Mentors; Mission; Mutation; National Heart, Lung, and Blood Institute; Oral; Outcome; Oxygen; Oxygen Consumption; Pathologic; Patient Recruitments; Patients; Pattern; Performance; Physiological; Placebos; Plasma; Population; Population Heterogeneity; Principal Investigator; Protocols documentation; Quality of life; Research; Research Design; Research Personnel; Role; Science; Site; Skeletal Muscle; System; Techniques; Testing; Therapeutic; Time; Training; Training Support; Translating; Ventricular Function; Woman; Work; arm; comparative effectiveness; cytokine; design; ethnic minority population; experience; hepcidin; improved; indexing; iron deficiency; member; metabolomics; next generation; novel; prevent; programs; randomized trial; rapid growth; response; skills; treatment strategy; uptake

DESCRIPTION (provided by applicant): The Harvard Regional Clinical Center (RCC) of the current NHLBI Heart Failure (HF) Network, including a Clinical Research Skills Development Core, looks forward to expanding into a triangle where 3 uniquely aligned and supported HF programs will accelerate the mission of the NHBLI to improve the future for HF patients. Study patient recruitment within this RCC will be enhanced through utilization of real-time databases and diversity of site populations. Creation of new Network Assets is planned, using common data fields that will bridge individual Network trials to multiply the scientific yield of the Netwrk. These Assets will inform current challenges in HF care, such as preventing hospitalizations, identifying new pathologic mutations in dilated cardiomyopathy, and characterizing patients with improved LVEF. The Harvard RCC will provide collaborative leadership for design and implementation of studies that address vital mechanistic and therapeutic questions that cannot be answered without NHLBI sponsorship. One example is a 3-arm comparative effectiveness study to determine Iron Repletion Effects on Exercise Capacity and Cardiac Function in Heart Failure (IRONOUT HF). This study will add to the understanding of the physiologic impact and explore treatments of iron deficiency in HF. The primary endpoint will be change in peak oxygen consumption after 24 weeks of intravenous iron, oral iron, or placebo. If benefit is shown, oral iron will be assessed for non-inferiority compared to the more expensive and inconvenient therapy with intravenous iron. This study will also assess skeletal muscle oxygen utilization during low level exercise, and relate changes in hemoglobin, iron stores, the iron-regulatory protein hepcidin, and novel iron-dependent metabolomic profiles to changes in exercise capacity in order to identify patients most likely to benefit from iron repletion. The Clinical Research Skills Development Core supports a rigorous course curriculum, hands-on-laboratory experience, and a Mentor Review Board to train and inspire new HF clinical investigators. Utilizing the Network Assets, an Apprentice Investigator Network is planned where fellows throughout the HF Network will collaborate to become the next generation of clinical investigators. RELEVANCE (See instructions): Heart failure is a growing burden on US health that can only be diminished by the collaboration of leading investigators through initiatives such as the NHLBI Heart Failure Network. The Harvard Regional Clinical Center proposes to join other leaders in the field in studies such as IRONOUT HF, testing whether treatment of iron deficiency in heart failure patients with either oral or intravenous iron will improve exercise capacity.

描述（由申请人提供）：目前NHLBI心力衰竭（HF）网络的哈佛地区临床中心（RCC），包括临床研究技能发展核心，期待扩展成一个三角形，其中3个独特的联合和支持的HF项目将加速NHBLI的使命，改善HF患者的未来。通过利用实时数据库和现场人群的多样性，该RCC的研究患者招募将得到加强。计划创建新的网络资产，使用公共数据字段，将连接单个网络试验，以增加网络的科学成果。这些资产将为当前心衰护理的挑战提供信息，例如预防住院治疗，识别扩张型心肌病的新病理突变，以及描述LVEF改善患者的特征。哈佛RCC将为研究的设计和实施提供协作领导，解决没有NHLBI赞助就无法回答的重要机制和治疗问题。一个例子是一项确定铁补充对心力衰竭患者运动能力和心功能影响的3组比较有效性研究（IRONOUT HF）。本研究将增加对心衰缺铁生理影响的认识，并探索治疗方法。主要终点将是静脉注射铁、口服铁或安慰剂治疗24周后的峰值耗氧量变化。如果显示出益处，口服铁将被评估为与更昂贵和不方便的静脉注射铁治疗相比的非劣效性。本研究还将评估低水平运动时骨骼肌的氧利用率，并将血红蛋白、铁储存、铁调节蛋白hepcidin和新的铁依赖性代谢组学特征的变化与运动能力的变化联系起来，以确定最有可能从铁补充中受益的患者。临床研究技能发展核心支持严格的课程设置、实验室实践经验和导师审查委员会，以培训和激励新的心衰临床研究者。利用网络资产，计划建立一个学徒调查员网络，整个HF网络的研究员将合作成为下一代临床调查员。