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

用于在家治疗心力衰竭的一次性 NT-proBNP 传感器

• 批准号: 9353541
• 负责人: RICHARD M CROOKS
• 金额: $ 55.53万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9353541
• 关键词: 20 year old; Acute; Address; Adrenergic beta-Antagonists; Age; Aging; Aldosterone; Ambulatory Care; American Heart Association; Antibodies; Biological Assay; Biological Markers; Blood; Blood Glucose; Buffers; Cardiology; Caring; Chronic; Clinical; Clinical Treatment; Collaborations; Communication; Communities; Country; Detection; Development; Device Designs; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Diuretics; Economics; Elderly; Electronics; Emergency department visit; Emergency treatment; Ensure; European; Face; Glucose; Goals; Gold; Healthcare; Healthcare Systems; Heart failure; Home environment; Hospitalization; Human; Individual; Innovation Corps; Intervention; Length of Stay; Measurement; Measures; Medical; Medicare; Medication Management; Methods; Mission; Modeling; Monitor; Myocardial; Natriuretic Peptides; Nurse Practitioners; Outcome; Patient Care; Patient Care Management; Patient Monitoring; Patients; Perioperative Nursing; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Physicians; Physiological; Pilot Projects; Plasma; Population; Prevalence; Process; Quality of Care; Quality of life; Reagent; Research; Research Project Grants; Resources; Route; Sample Size; Sampling; Serum; Societies; Stress; Stretching; System; Systolic heart failure; Test Result; Testing; Therapeutic; Time; Titrations; Treatment Failure; United States; United States National Institutes of Health; Variant; Vasodilator Agents; Visit; Wireless Technology; Work; aged; aging population; base; beneficiary; cardiac resynchronization therapy; cardiovascular health; clinical decision-making; college; cost; design; diabetic; economic cost; glucose monitor; health economics; improved; improved outcome; mortality; new technology; novel; palliative; patient home care; patient population; persistent symptom; pro-brain natriuretic peptide (1-76); programs; prototype; sensor; standard of care; statistics; stress management; tool

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.

项目总结/摘要 在美国，超过500万人具有临床表现的心力衰竭（HF），并且该数字 随着该国人口老龄化对医疗保健系统造成严重压力， 以及巨大的经济成本。诊断和管理心血管健康问题， 人口，特别是老年人谁也往往患有糖尿病，创造了新的需求不断增长， 医疗保健范例将有助于：（1）适应衰老和糖尿病HF的身体挑战 患者和（2）降低医疗成本和医疗资源的压力。利钠尿肽水平升高 肽生物标志物NT-proBNP和BNP指示心肌应激的存在，并且在HF患者中， 这些已经显示与该病症的急性恶化相关。利钠尿肽定量 肽水平对于确定适当的紧急和临床治疗是至关重要的， 目前唯一一种用于诊断心肌应激和管理HF的血液检测方法。 利钠肽用于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降低。这个项目的目标是 开发一种家用传感系统，允许HF患者监测其NT-proBNP水平， 就像糖尿病患者监测血糖水平一样。该项目建立在广泛的 初步研究，导致了预原型传感器设计。在这个早期阶段， 开发，传感器能够检测NT-proBNP在缓冲液中的临床实用范围附近的水平， 实验台在本提案中，描述了一个雄心勃勃的计划，以进一步开发传感器， 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专家， 调整病人的用药。重要的是，这项工作的目标是监测那些已经 被诊断患有HF;也就是说，它不是作为诊断工具，而是一种患者护理工具， 指导适当的治疗并创造更好的结果。 具体目标包括开发能够整体检测NT-proBNP的传感器平台 人血在适合NYHA I-III级HF患者的动态范围内。在与一个 根据心脏病专家的建议，将使用实际HF患者的血液对传感器进行测试，所得统计数据将为 与使用金标准方法获得的结果相比。最后，与世界一流的顾问合作， 计划将制定一个系统设计，将监管影响和卫生经济学相结合 分析以确定报销途径。改善临床决策的机会， 特别是在住院治疗和返回社区方面，直接涉及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起来。