权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

批准号：
9977701
负责人：
RICHARD M CROOKS
金额：
$ 47.08万
依托单位：
UNIVERSITY OF TEXAS AT AUSTIN
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9977701
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 Financial Hardship Glucose Goals Gold Healthcare Healthcare Systems Heart failure Home environment Hospitalization Human Individual Innovation Corps Intervention Length of Stay Measurement Measures Medical Medical Care Costs Medicare Medication Management Methods Mission Modeling Monitor Myocardial Natriuretic Peptides Nurse Practitioners Outcome Patient Care Patient Care Management Patient Monitoring Patients 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 economic evaluation 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

项目摘要

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.

项目概要/摘要在美国有超过 500 万人患有临床表现的心力衰竭 (HF)，而这个数字随着该国人口老龄化的加剧，医疗保健系统面临严重压力并付出巨大的经济代价。诊断和管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，对新产品的需求日益增长医疗保健范式将有助于：(1) 适应衰老和糖尿病性心力衰竭的身体挑战 (2) 降低医疗成本和医疗资源压力。利尿钠水平升高肽生物标志物 NT-proBNP 和 BNP 表明心肌应激的存在，并且在心力衰竭患者中，这些已被证明与这种情况的急性恶化有关。尿钠定量肽水平对于确定适当的紧急和临床治疗至关重要，目前唯一用于诊断心肌应激和治疗心力衰竭的基于血液的检测方法。使用利钠肽指导药物治疗和诊断的研究表明，死亡率以及住院次数和住院时间显着降低。该项目的目标是开发家用传感系统，使心力衰竭患者能够监测他们的 NT-proBNP 水平在家中，就像糖尿病患者监测血糖水平一样。该项目建立在广泛初步研究产生了预原型传感器设计。在其早期阶段开发中，该传感器能够检测缓冲液中接近临床实用范围的水平的 NT-proBNP 实验台。在目前的提案中，描述了一个雄心勃勃的计划，以进一步开发传感器，并制定详细计划，将其纳入完整的监测系统。 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，然后他们可以远程进行调整患者的用药。重要的是，这项工作的目标是监测已经患有此病的患者被诊断患有心力衰竭；也就是说，它并不是作为诊断工具，而是作为患者护理工具来帮助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全面检测 NT-proBNP 的传感器平台人体血液的动态范围适合 NYHA I-III 级心力衰竭患者。与合作心脏病专家将使用实际心力衰竭患者的血液对传感器进行测试，得出的统计数据将是与使用金标准方法获得的结果进行比较。最后，与世界一流的顾问合作，将制定系统设计计划，其中纳入监管影响和健康经济学分析以确定报销途径。改善临床决策的机会，特别是在住院和返回社区方面，直接解决了 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。