A disposable NT-proBNP sensor for managing heart failure at home

项目摘要/摘要 在美国，有500多万人在临床上表现出心力衰竭(HF)，而这个数字 继续上升，该国老龄化的人口给医疗保健系统带来了严重的压力 以及巨大的经济成本。诊断和处理如此大的心血管健康问题 人口，特别是经常患有糖尿病的老年人，创造了对新的 医疗保健范例将有助于：(1)适应老龄化和糖尿病心衰的身体挑战 (2)降低医疗成本，减轻医疗资源压力。脑利钠水平升高 多肽生物标记物NT-proBNP和BNP指示心肌应激的存在，在心力衰竭患者中， 这些已被证明与这种情况的急性加重有关。利钠药的定量 多肽水平对确定适当的急救和临床治疗至关重要，目前 这是唯一一种基于血液的检测方法，可用于诊断心肌应激和治疗心力衰竭。 使用利钠肽来指导药物治疗和诊断的研究表明 死亡率和住院次数和住院时间显著减少。这个项目的目标是 开发一种家用传感系统，使心力衰竭患者能够监测他们的NT-proBNP水平 在家，就像糖尿病患者监测他们的血糖水平一样。该项目建立在广泛的基础上 初步研究已经导致了传感器的预原型设计。在其非常早期的阶段 经过开发，该传感器能够在接近临床使用范围的缓冲液中检测NT-proBNP 实验室长椅。在本提案中，描述了一项雄心勃勃的计划，以进一步开发传感器，并 制定详细的计划，将其纳入一个完整的监测系统。NT-的定量结果 ProBNP测试将通过无线技术提供给患者的心脏病医生，然后他们可以远程 调整病人的用药。重要的是，这项工作的目标是监测已经 被诊断出患有心力衰竭；也就是说，它不是作为一种诊断工具，而是一种帮助患者护理的工具 指导适当的治疗，创造更好的结果。 具体目标包括开发一种能够整体检测NT-proBNP的传感器平台 适用于NYHA I-III级心衰患者的动态范围内的人血。与 心脏病专家表示，该传感器将使用实际心力衰竭患者的血液进行测试，结果将是 与使用黄金标准方法获得的结果进行比较。最后，与世界级的顾问合作， 将制定将监管影响和卫生经济相结合的系统设计计划 分析以确定报销途径。改善临床决策的机会， 特别是在住院和重返社区方面，直接针对NIH的使命 提高护理质量，降低成本，并将生理变化与医疗干预更紧密地结合在一起。

Project Summary/Abstract More than 5 million individuals in the United States have clinically manifest Heart Failure (HF), and that number continues to rise with the country's aging population contributing to serious strains on the healthcare system and to huge economic costs. Diagnosing and managing the cardiovascular health concerns for such a large population, particularly the elderly who often also suffer from diabetes, has created a growing need for new healthcare paradigms that will help: (1) accommodate the physical challenges of aging and diabetic HF patients and (2) lower medical cost and the strain on healthcare resources. Elevated levels of natriuretic peptide biomarkers NT-proBNP and BNP indicate the presence of myocardial stress, and in people with HF, these have been shown to correlate with acute exacerbations of this condition. Quantitation of natriuretic peptide levels is critical to the determination of appropriate emergency and clinical treatment, and currently is the only blood-based assay that exists for the diagnosis of myocardial stress and management of HF. Studies where natriuretic peptides were used to guide drug therapies and diagnostics suggest reduced mortality and a significantly lowered number and duration of hospital stays. The goal of this project is development of a home-use sensing system that will allow HF patients to monitor their level of NT-proBNP at home, in much the same way that diabetics monitor their blood glucose levels. The project builds on extensive preliminary research that has resulted in a pre-prototype sensor design. At this very early stage in its development, the sensor is able to detect NT-proBNP at levels near the range of clinical utility in buffer at the lab bench. In the present proposal an ambitious plan is described to develop the sensor further and also to develop detailed plans for incorporating it into a complete monitoring system. The quantitative result of the NT- proBNP test would be available, via wireless technology, to the patient's cardiologist who may then remotely adjust the patient's medications. Importantly, the goal of the work is to monitor patients who have already been diagnosed with HF; that is, it is not intended as a diagnostic tool, but rather a patient care tool to help guide appropriate therapy and create better outcomes. The specific aims include development of a sensor platform capable of detecting NT-proBNP in whole human blood over a dynamic range appropriate for NYHA class I-III HF patients. In collaboration with a cardiologist, the sensor will be tested using blood from actual HF patients, and the resulting statistics will be compared to those obtained using a gold-standard method. Finally, working with world-class consultants, plans will be developed for a system design that incorporates the regulatory impacts and a health economics analysis to identify the routes to reimbursement. The opportunity to improve clinical decision-making, especially in relation to hospitalization and return to the community, directly addresses the NIH mission to improve quality of care, reduce costs, and more closely couple physiological changes to medical intervention.