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

摘要 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 百万次住院治疗。摘要急性失代偿性心力衰竭(ADHF)是一种新发或恶化的临床综合征。 出血热的体征和症状，经常导致住院。在出院后30天内，大约每30天就有一人 4名ADHF患者再次住院，每9人中就有1人死亡。ADHF最常见的原因是心脏重构 心脏因血管内血浆滞留量过多而引起的BV调节疗法，主要 利尿剂，最常见的治疗方法。然而，标准的不完善使它们的使用变得混乱。 体检，患者生理高度异质性，以及标准护理代理测试的不准确性 BV.治疗过度和治疗不足都构成重大风险，突显了对工具的需求，这些工具能够实现精确的 个性化护理。Daxor公司的BVA-100可提供98%准确的全血定量测量 体积、血浆体积和红细胞体积，然后将其与经过验证的患者特定正常值进行比较 以提供血管内血液容量组成和排列紊乱的准确测量。最近 回溯性倾向匹配对照分析显示，30天的再入院时间减少了56% 心力衰竭患者30天死亡率降低82%，365天死亡率降低86%。 因ADHF而入院的射血分数由BVA评估指导住院治疗。过渡到这一点 临床验收的初步成功需要进行大型、多中心的前瞻性研究 比较标准护理与BVA引导治疗策略的疗效和成本，以及 在不同的ADHF患者范围内建立一种经过验证的、详细的治疗方法。这 建议的第一阶段应用程序包括概念验证前瞻性、双中心、并行设计、 干预性、单盲、先导性研究，比较标准护理治疗决策的疗效 精确度由BVA-100提高。如果这项研究表明，在BVA指导下进行治疗会导致更多 与标准护理指导的护理相比，出院前有效实现患者特定容量目标 单独来说，Daxor将提出随后的更大规模的多站点研究(第二阶段SBIR)，以证明重新入院和 与标准护理相比，在30天和90天的基础上降低死亡率、降低总体护理成本等 在入院和出院时对患者进行有效的分流，以避免不必要的入院/再入院，同时 同时指导特定于HF的决策支持算法的开发和验证。

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.