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Daxor - Blood Volume Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111185
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
Duke University

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
Heart Failure Congestive Heart Failure Device: Receive Blood Volume Analysis Guided Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : July 16, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: 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.



Primary Outcome Measures :
  1. Change in plasma and whole blood volume [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, day 1, day 2, day 3 and discharge (up to day 5) ]
    Comparison of baseline to follow up times



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111185


Contacts
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Contact: Stephanie Newbold 919-613-4728 stephanie.newbold@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: G. Michael Felker, MD         
Sponsors and Collaborators
Duke University
Daxor Corporation
Investigators
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Principal Investigator: G. Michael Felker, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04111185    
Other Study ID Numbers: Pro00102851
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases