Monitoring Outpatient Blood VolumE in Heart Failure

Study Overview
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Brief Summary
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In patients discharged following heart failure treatment, the consistency of blood volume status and components over time is unknown. The primary objective is to describe the rate of change, if any, of the plasma volume and red blood cell volume following hospitalization and discharge of patients with heart failure.

Detailed Description
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Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases. High 30-day readmission and mortality rates have persisted despite advances in care. Clinical guidelines suggest blood volume assessment and clinical management to euvolemia or normal blood volume, but standard methods of blood volume diagnosis have been shown to be unreliable. FDA-cleared Blood volume analysis (BVA) has been used to quantify otherwise undiagnosed blood volume derangements in heart failure and other indications. Also, care guided by BVA has been demonstrated to improve inpatient heart failure readmission and mortality. A similar analysis has not previously been performed immediately following hospital discharge, though this period is understood to be challenging due to high variability of patient status, physiology, and compliance. This is a prospective, single-center, observational open-label study. The primary objective is to quantify changes to plasma volume and red blood cell volume over a 12 week period post-discharge.

Official Title
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Monitoring Outpatient Blood VolumE in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: BVA-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized male and female patients with primary or secondary admission diagnosis of acute heart failure exacerbation > 18 years of age Able and willing to provide consent Reduced or preserved LVEF Exclusion Criteria: Diagnosed with current acute strokes Pregnant women Severe hypotension requiring resuscitation, intubation or circulatory support Cardiogenic shock Patients with known cardiac amyloid and hypotension Known allergy to iodine or iodinated albumin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients following discharge for treatment of heart failure<br>Daxor Corporation's commercially available Blood Volume Analyzer, BVA-100, will be performed at 5 timepoints for each patient. | Device: BVA-100<br>* The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in 131I -HSA). Data inputs to the software come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and transudation rate are reported, with statistics showing the quality of the results. The subject blood samples and calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify volume shifts in post discharge heart failure patients | Accurately quantify changes to plasma volume and red blood cell volume in HF outpatients over the 12-week period following discharge. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Volume, Diuresis, Plasma Volume, Red Blood Cell Volume