Development and validation of precision blood volume diagnostic and decision support device for acute decompensated heart failure

急性失代偿性心力衰竭精准血容量诊断和决策支持装置的开发和验证

基本信息

批准号：
10474788
负责人：
Jonathan Feldschuh
金额：
$ 15.73万
依托单位：
DAXOR CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-30 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10474788
关键词：
Achievement Acute Address Admission activity Affect Affordable Care Act Algorithms American Americas Blinded Blood Plasma Volume Blood Tests Blood Volume Cardiology Caring Cell Volumes Cessation of life Clinical Clinical assessments Comparative Study Congestive Heart Failure Data Decision Making Development Devices Diagnosis Diagnostic Dilution Techniques Diuresis Diuretics EFRAC Educational Status Erythrocytes Evaluation Goals Gold Guidelines Health system Heart Heart failure Heterogeneity Hospitalization Hospitals Iatrogenesis Incentives Inpatients Intervention Knowledge Manufacturer Name Measurement Measures Methodology Observational Study Outcome Patient Care Patient Triage Patient-Focused Outcomes Patients Peer Review Performance Phase Physical Examination Physicians Physiology Pilot Projects Population Heterogeneity Positioning Attribute Prospective Studies Protocols documentation Proxy Publications Recommendation Retrospective Studies Risk Sensitivity and Specificity Signs and Symptoms Single-Blind Study Site Small Business Innovation Research Grant Societies Syndrome System Technology Testing Tracer Training Treatment Failure Validation Veterans Health Administration acute care acute symptom base care costs clinical decision support college commercial application common treatment comparative efficacy cost design experience hospital readmission improved inpatient service maltreatment mortality personalized care personalized diagnostics prospective standard care success support tools technological innovation tool treatment guidelines treatment strategy user-friendly

项目摘要

Abstract Heart failure (HF) affects nearly 6 million Americans annually, leading to nearly 1 million deaths and 1 million hospitalizations. Acute decompensated heart failure (ADHF) is a clinical syndrome of new or worsening signs and symptoms of HF, frequently resulting in hospitalization. Within 30 days of discharge, roughly one in four ADHF patients is rehospitalized and one in nine is dead. ADHF is most commonly caused by remodeling of the heart due to excessive retention of intravascular plasma volume making BV adjusting therapies, primarily diuretics, the most common treatments. However, their use is confounded by the inadequacy of the standard physical examination, high heterogeneity of patient physiology, and inaccuracy of standard care proxy tests for BV. Both over- and under-treatment pose significant risks highlighting the need for tools that enable precise individualization of care. Daxor’s BVA-100, provides 98% accurate quantitative measurement of total blood volume, plasma volume, and red blood cell volume, which it then compares to validated patient-specific norms to provide an accurate measure of intravascular blood volume composition and derangement. A recent retrospective propensity-matched control analysis demonstrated a 56% reduction in 30-day readmissions, an 82% reduction in 30-day mortality, and an 86% reduction in 365-day mortality for patients with HF and mixed– ejection fraction admitted for ADHF in whom inpatient care was guided by BVA assessments. Transitioning this initial success to clinical acceptance requires the performance of a large, multi-center prospective study comparing the efficacy and cost of standard care to that of a BVA guided treatment strategy, and the establishment of a proven, detailed treatment methodology across the diverse spectrum of ADHF patients. This proposed Phase I application consists of a proof-of-concept prospective, two-center, parallel design, interventional, single-blinded pilot study to compare the efficacy of standard care treatment decisions to those with accuracy enhanced by BVA-100. If this study demonstrates that treatment guided by BVA results in more effective achievement of patient-specific volume targets prior to discharge than care guided by standard care alone, Daxor will propose a subsequent larger multisite study (Phase II SBIR) to demonstrate readmission and mortality reduction over a 30-day and 90-day basis versus standard care, lower overall cost of care, and more effective triage of patients at admission and discharge to avoid unnecessary admissions/readmissions, while simultaneously guiding the development and validation of an HF-specific decision support algorithm.

抽象的心力衰竭（HF）每年影响近600万美国人，导致近100万人死亡和1人百万住院。急性代偿性心力衰竭（ADHF）是一种新的或恶化的临床综合征 HF的体征和症状，经常导致住院。在出院后的30天内，大约有一个四名ADHF患者被重新住院，九分之一已死亡。 ADHF最常见由重塑引起由于过度保留血管内血浆体积的心脏，使BV调整疗法，主要利尿剂，最常见的治疗方法。但是，它们的使用被标准的不足所困扰体格检查，患者生理的高异质性以及标准护理代理测试的不准确性 BV。过度和不足的构成了重大风险，强调了对工具的需求个性化护理。 Daxor的BVA-100，提供98％的准确定量测量总血液体积，血浆体积和红细胞体积，然后与经过验证的患者特异性规范进行比较提供精确测量血管内血容量组成和进化。最近回顾性改进匹配的控制分析表明，30天的再入院减少了56％ 30天死亡率降低了82％，HF和混合患者的365天死亡率降低了86％ ADHF的射血分数是由BVA评估指导的ADHF。过渡临床接受的最初成功需要进行大型多中心的前瞻性研究将标准护理的效率和成本与BVA指导治疗策略的效率和成本进行比较，在ADHF患者的不同范围内建立了经过验证的详细治疗方法。这建议的I期应用程序由概念证明的前瞻性，两个中心的平行设计，介入的单叶试点研究，以将标准护理治疗决策的效率与那些进行比较 BVA-100的准确增强。如果这项研究证明了BVA指导的治疗导致更多出院前，有效实现特定于患者的体积目标，而不是标准护理指导的护理单独使用Daxor将提出一项随后的较大的多站点研究（II期SBIR），以证明再入院和在30天和90天的基础上与标准护理相比，降低的死亡率降低，整体护理成本降低，更多入院和出院时的有效分类以避免不必要的入院/再入院，而同样，指导特定于HF的决策支持算法的开发和验证。