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Daxor - Blood Volume Analysis

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04111185
Collaborator
Daxor Corporation (Industry)
33
Enrollment
1
Location
2
Arms
14.3
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Receive Blood Volume Analysis Guided Treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Blood Volume Analysis - Guided Heart Failure Management
Actual Study Start Date :
Jul 16, 2020
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Sep 23, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in plasma and whole blood volume [Baseline, and upon discharge (up to day 5)]

    Secondary Outcome Measures

    1. Change in congestion metrics as measured with a clinical congestion score (pulmonary edema, jugular venous pressure, lower extremity edema and PND) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    2. Change in mean NTpro-BNP concentration (in pg/mL) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    3. Change in weight (in kg) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    4. Change in renal function as measured by creatinine (mg/dL) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    5. Change in renal function as measured by blood urea nitrogen (mg/dL) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    6. Change in renal function as measured by an estimated glomerular filtration rate (mL/min/ 1.73m2) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    7. Change in pulmonary congestion as measured using non-invasive diagnostic technology such as the ReDS vest (radiofrequency) or bio-impedance based technologies (unitless values) [Baseline, day 1, day 2, day 3 and discharge (up to day 5)]

      Comparison of baseline to follow up times

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, NC
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • Daxor Corporation

    Investigators

    • Principal Investigator: G. Michael Felker, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04111185
    Other Study ID Numbers:
    • Pro00102851
    First Posted:
    Oct 1, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Nov 2, 2021