Daxor - Blood Volume Analysis

Study Overview
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Brief Summary
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The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

Detailed Description
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The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.

Official Title
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Blood Volume Analysis - Guided Heart Failure Management

Conditions
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Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Device: Receive Blood Volume Analysis Guided Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina Exclusion Criteria: Age < 18 years Ongoing pregnancy Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days Post heart transplantation or ongoing mechanical circulatory support Progressive cardiogenic shock Patients with Ventricular Assist Devices End stage renal disease

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receive Blood Volume Analysis Guided Treatment<br>The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment. | Device: Receive Blood Volume Analysis Guided Treatment<br>* The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis<br>* Other names: Daxor BVA-100;|
| No Intervention: Receive Standard of Care Treatment<br>The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Whole Blood Volume |  | Baseline, and upon discharge (up to day 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND) | Comparison of baseline to follow up times | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | 
| Change in Mean NTpro-BNP Concentration (in pg/mL) |  | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge | 
| Change in Weight (in kg) |  | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge | 
| Change in Renal Function as Measured by Creatinine (mg/dL) |  | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge | 
| Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL) | Comparison of baseline to follow up times | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | 
| Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2) | Comparison of baseline to follow up times | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | 
| Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values) | Comparison of baseline to follow up times | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |