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：
10624504
负责人：
Jonathan Feldschuh
金额：
$ 5.5万
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：
2021-08-01 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10624504
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 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。心力衰竭的体征和症状，通常导致出院后 30 天内住院。四名 ADHF 患者再次住院，九分之一的 ADHF 最常见是由 ADHF 重塑引起的。由于血管内血浆容量过度滞留而导致心脏受损，因此主要进行 BV 调整疗法利尿剂是最常见的治疗方法，但其使用因标准的不充分而受到干扰。体格检查、患者生理学的高度异质性以及标准护理代理测试的不准确性 BV. 过度治疗和治疗不足都会带来显着的风险，凸显了对能够实现精确治疗的工具的需求。 Daxor 的 BVA-100 提供 98% 准确度的全血定量测量。体积、血浆体积和红细胞体积，然后与经过验证的患者特定标准进行比较提供血管内血容量成分和紊乱的准确测量。回顾性倾向匹配对照分析表明，30 天再入院率减少了 56%，心衰和混合型患者的 30 天死亡率降低了 82%，365 天死亡率降低了 86% 因 ADHF 住院治疗的射血分数由 BVA 评估指导。临床接受的初步成功需要进行大型、多中心前瞻性研究比较标准护理与 BVA 指导治疗策略的疗效和成本，以及为不同类型的 ADHF 患者建立行之有效的、详细的治疗方法。拟议的第一阶段应用包括概念验证前瞻性、两中心、并行设计，干预性、单盲试点研究，比较标准护理治疗决策与其他治疗决策的效果如果这项研究表明 BVA 指导的治疗效果更好，则 BVA-100 可以提高准确性。与标准护理指导下的护理相比，在出院前有效实现患者特定的容量目标仅凭这一点，Daxor 将提出后续更大规模的多中心研究（第二阶段 SBIR），以证明重新入院和与标准护理相比，30 天和 90 天的死亡率降低，总体护理成本降低等等在入院和出院时对患者进行有效分流，以避免不必要的入院/再入院，同时同时指导 HF 特定决策支持算法的开发和验证。