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Daxor - Blood Volume Analysis

Primary Purpose

Heart Failure, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receive Blood Volume Analysis Guided Treatment
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Receive Blood Volume Analysis Guided Treatment

Receive Standard of Care Treatment

Arm Description

The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's 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.

Outcomes

Primary Outcome Measures

Change in Whole Blood Volume

Secondary Outcome Measures

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
Change in Mean NTpro-BNP Concentration (in pg/mL)
Change in Weight (in kg)
Change in Renal Function as Measured by Creatinine (mg/dL)
Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)
Comparison of baseline to follow up times
Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)
Comparison of baseline to follow up times
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

Full Information

First Posted
September 23, 2019
Last Updated
June 8, 2023
Sponsor
Duke University
Collaborators
Daxor Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04111185
Brief Title
Daxor - Blood Volume Analysis
Official Title
Blood Volume Analysis - Guided Heart Failure Management
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Daxor Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Receive Blood Volume Analysis Guided Treatment
Arm Type
Experimental
Arm Description
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Arm Title
Receive Standard of Care Treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Receive Blood Volume Analysis Guided Treatment
Other Intervention Name(s)
Daxor BVA-100
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Whole Blood Volume
Time Frame
Baseline, and upon discharge (up to day 18)
Secondary Outcome Measure Information:
Title
Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)
Description
Comparison of baseline to follow up times
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Title
Change in Mean NTpro-BNP Concentration (in pg/mL)
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Title
Change in Weight (in kg)
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Title
Change in Renal Function as Measured by Creatinine (mg/dL)
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Title
Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)
Description
Comparison of baseline to follow up times
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Title
Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)
Description
Comparison of baseline to follow up times
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Title
Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)
Description
Comparison of baseline to follow up times
Time Frame
Baseline, day 1, day 2, day 3 and discharge (up to day 18)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Michael Felker, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Daxor - Blood Volume Analysis

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