Heart failure (HF) affects nearly 6 million Americans annually, leading to nearly 1 million deaths and 1million hospitalizations. Acute decompensated heart failure (ADHF) is a clinical syndrome of new or worseningsigns and symptoms of HF, frequently resulting in hospitalization. Within 30 days of discharge, roughly one infour ADHF patients is rehospitalized and one in nine is dead. ADHF is most commonly caused by remodeling ofthe heart due to excessive retention of intravascular plasma volume making BV adjusting therapies, primarilydiuretics, the most common treatments. However, their use is confounded by the inadequacy of the standardphysical examination, high heterogeneity of patient physiology, and inaccuracy of standard care proxy tests forBV. Both over- and under-treatment pose significant risks highlighting the need for tools that enable preciseindividualization of care. Daxor's BVA-100, provides 98% accurate quantitative measurement of total bloodvolume, plasma volume, and red blood cell volume, which it then compares to validated patient-specific normsto provide an accurate measure of intravascular blood volume composition and derangement. A recentretrospective propensity-matched control analysis demonstrated a 56% reduction in 30-day readmissions, an82% 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 thisinitial success to clinical acceptance requires the performance of a large, multi-center prospective studycomparing the efficacy and cost of standard care to that of a BVA guided treatment strategy, and theestablishment of a proven, detailed treatment methodology across the diverse spectrum of ADHF patients. Thisproposed 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 thosewith accuracy enhanced by BVA-100. If this study demonstrates that treatment guided by BVA results in moreeffective achievement of patient-specific volume targets prior to discharge than care guided by standard carealone, Daxor will propose a subsequent larger multisite study (Phase II SBIR) to demonstrate readmission andmortality reduction over a 30-day and 90-day basis versus standard care, lower overall cost of care, and moreeffective triage of patients at admission and discharge to avoid unnecessary admissions/readmissions, whilesimultaneously guiding the development and validation of an HF-specific decision support algorithm.
Public Health Relevance Statement: Narrative
Heart failure (HF) affects nearly 6 million Americans leading to nearly 1 million deaths, 1 million hospitalizations,
and tens of billions of dollars of cost annually. Acute decompensated heart failure, a clinical syndrome of new or
worsening signs and symptoms of acute or chronic HF, is most commonly treated with volume adjusting
therapies, primarily diuretics. However, their use is confounded by the inadequacy of the standard physical
examination, high heterogeneity of patient physiology, and lack of sensitivity and specificity of standard care
proxy tests for blood volume. 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 alone
to care enhanced by BVA-100, the gold standard diagnostic for intravascular volume measurement, in achieving
the treatment goal of intravascular euvolemia or normal BV.
Project Terms: Achievement ; Achievement Attainment ; Affect ; Algorithms ; Americas ; Blood Volume ; Cardiology ; Comparative Study ; Cessation of life ; Death ; Decision Making ; Diagnosis ; Diuresis ; Diuretics ; Educational Status ; Educational Achievement ; educational level ; training achievement ; training level ; training status ; Erythrocytes ; Blood erythrocyte ; Erythrocytic ; Marrow erythrocyte ; Red Blood Cells ; Red Cell ; blood corpuscles ; Patient Care ; Patient Care Delivery ; Goals ; Gold ; Heart ; Heart failure ; cardiac failure ; Congestive Heart Failure ; Cardiac Failure Congestive ; Heart Decompensation ; chronic heart failure ; Blood Tests ; Hematologic Tests ; Hematological Tests ; Hematology Testing ; Heterogeneity ; Hospitalization ; Hospital Admission ; Hospitals ; Incentives ; Inpatients ; Methodology ; mortality ; Patients ; Peer Review ; Physical Examination ; Medical Inspection ; Physicians ; Physiology ; Pilot Projects ; pilot study ; Blood Plasma Volume ; Plasma Volume ; Prospective Studies ; Publications ; Scientific Publication ; Recommendation ; Retrospective Studies ; Risk ; Sensitivity and Specificity ; Signs and Symptoms ; Diagnostic Findings ; Societies ; Syndrome ; Technology ; Testing ; Dilution Techniques ; Dilution Technics ; Measures ; Population Heterogeneity ; diverse populations ; heterogeneous population ; population diversity ; Blinded ; Caring ; Treatment Failure ; therapy failure ; Guidelines ; base ; improved ; Site ; Acute ; Clinical ; Phase ; Evaluation ; Training ; Measurement ; Single-Blind Study ; Single-blind ; tool ; Diagnostic ; Knowledge ; Protocol ; Protocols documentation ; System ; Ejection Fraction ; EFRAC ; collegiate ; college ; American ; Cell Volumes ; experience ; Performance ; success ; hospital re-admission ; re-admission ; re-hospitalization ; readmission ; rehospitalization ; hospital readmission ; Proxy ; technological innovation ; Devices ; Position ; Positioning Attribute ; Admission ; Admission activity ; Intervention Strategies ; interventional strategy ; Intervention ; Manufacturer ; Manufacturer Name ; Address ; Health system ; Data ; iatrogenic ; iatrogenically ; iatrogenicity ; Iatrogenesis ; Observational Study ; Observation research ; Observation study ; Observational research ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Tracer ; Development ; developmental ; cost ; inpatient service ; inpatient care ; design ; designing ; Clinical assessments ; maltreatment ; mistreatment ; Outcome ; prospective ; user-friendly ; commercial application ; treatment strategy ; common treatment ; standard care ; standard treatment ; comparative efficacy ; compare efficacy ; Patient Triage ; personalized diagnostics ; personalized diagnosis ; precise diagnostics ; precision diagnostics ; personalized care ; Precision care ; individualized care ; individualized patient care ; personalized patient care ; support tools ; Affordable Care Act ; Obamacare ; acute symptom ; care costs ; clinical decision support ; treatment guidelines ; acute care ; Veterans Health Administration ; Veterans Health Affairs ;
