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: 8588996
• 负责人: MICHAEL M GIVERTZ
• 金额: $ 49.19万
• 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/8588996
• 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

The Harvard Regional Clinical Center (RCC) ofthe current NHLBi Heart Failure (HF) Network, including a Clinical Research Skills Development Core, looks fonA/ard to expanding into a triangle where 3 uniquely aligned and supported HF programs will accelerate the mission ofthe 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 ofthe Network. 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 ofthe 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.

目前NHLBi心力衰竭（HF）网络的哈佛地区临床中心（RCC），包括一个 临床研究技能发展核心，看起来很难扩展成一个三角形，其中3个独特的 协调一致和得到支持的高频项目将加速NHBLI的使命，以改善高频的未来 患者将通过利用实时 数据库和网站人口的多样性。计划使用通用数据创建新的网络资产 这些领域将连接单个网络试验，以增加网络的科学产量。这些资产将 告知HF护理中的当前挑战，例如预防住院，识别新的病理性 扩张型心肌病中的突变，并表征LVEF改善的患者。哈佛RCC将 为设计和实施研究提供协作领导，这些研究涉及重要的机械和 没有NHLBI赞助就无法回答的治疗问题。一个例子是三臂 比较有效性研究，以确定铁补充对运动能力和心脏的影响 心力衰竭功能（IRONOUT HF）。这项研究将增加对生理影响的理解 探讨心衰缺铁的治疗方法。主要终点将是峰值氧浓度的变化 24周后，静脉注射铁，口服铁或安慰剂。如果有效果，口服铁剂 评估了与更昂贵和不方便的静脉内给药治疗相比的非劣效性 铁.本研究还将评估低水平运动时骨骼肌的氧利用率， 血红蛋白、铁储存、铁调节蛋白铁调素和新的铁依赖性蛋白的变化。 代谢组学特征与运动能力的变化，以确定最有可能受益于 铁的补充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，以及导师审查委员会，以培训和激励新的HF临床 investigators.计划利用网络资产建立学徒调查员网络， 在整个HF网络将合作，成为下一代的临床研究者。 相关性（参见说明）： 心力衰竭是美国健康的一个日益沉重的负担，只有通过领导者的合作才能减轻。 研究人员通过NHLBI心力衰竭网络等倡议。哈佛地区临床 中心建议加入该领域的其他领导者的研究，如IRONOUT HF，测试是否治疗 缺铁性心力衰竭患者无论口服或静脉补铁都能提高运动能力。