Daxor - Blood Volume Analysis

Blood Volume Analysis - Guided Heart Failure Management

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Device: Receive Blood Volume Analysis Guided Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receive Blood Volume Analysis Guided Treatment; 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; 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; Other Names: Daxor BVA-100
No Intervention: Receive Standard of Care Treatment; 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?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Daxor Corporation
• Investigators: Principal Investigator: G. Michael Felker, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Pro00102851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No