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Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure

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ClinicalTrials.gov Identifier: NCT04855097
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : July 27, 2022
Sponsor:
Collaborators:
VA Boston Healthcare System
Minneapolis Veterans Affairs Medical Center
Information provided by (Responsible Party):
Daxor Corporation

Brief Summary:
Diuretic therapy is first-line treatment for acute decompensated heart failure. However, accurate assessment and management of patient blood volume is challenged by the limitations of physical exam and surrogate markers for blood volume. The study primary objective is to determine if goal-directed care as quantified by direct Blood Volume Analysis (Daxor BVA-100™) in addition to usual care results in more appropriate treatment and consistent achievement of euvolemia.

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Diagnostic Test: BVA-100 Not Applicable

Detailed Description:

Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases in the United States. High rates of rehospitalization and mortality and treatment costs have persisted for decades despite advances in care. Clinical guidelines recommend assessment of blood volume and clinical management to euvolemia or normal blood volume, but standard methods of diagnosing blood volume status have been shown to be unreliable. Blood Volume Analysis (Daxor BVA-100) is based on the gold standard indicator dilution technique. BVA has been used to quantify otherwise undiagnosed blood volume derangements and guide treatment in heart failure and other indications. Also, retrospective analyses have shown that care of heart failure patients guided by BVA is associated with improved rates of rehospitalization and mortality.

The proposed study is a prospective, two-center, parallel design, interventional, single-blinded pilot study of the potential for BVA to positively impact the treatment decisions of ADHF clinicians.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, two-center, parallel design, interventional, single-blinded pilot study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants and treating physicians will have no access to the BVA data in the Standard Care arm.
Primary Purpose: Treatment
Official Title: Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Standard care group
Blood Volume Analysis will be performed at admission, during inpatient stay if warranted, and prior to hospital discharge. Treating physicians will be blinded to the results and will choose between a low-moderate and high diuretic dose based on usual care clinical assessment of volume status.
Diagnostic Test: BVA-100
The BVA-100 is a medical device that calculates human blood volume using the method of tracer dilution. The device utilizes a tracer of human serum albumin tagged with iodine-131 to measure injected intravascularly and a series of timed blood draws. The amount of tracer in each blood draw is used to calculate the unknown blood volume. Data inputs come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and tracer transudation rate are reported, with statistics showing the quality of the results.

Experimental: BVA-guided treatment arm
Blood Volume Analysis will be performed at admission, during inpatient stay if warranted, and prior to hospital discharge. Treating physicians will receive the results and will choose between a low-moderate and high diuretic dose based on measured volume status.
Diagnostic Test: BVA-100
The BVA-100 is a medical device that calculates human blood volume using the method of tracer dilution. The device utilizes a tracer of human serum albumin tagged with iodine-131 to measure injected intravascularly and a series of timed blood draws. The amount of tracer in each blood draw is used to calculate the unknown blood volume. Data inputs come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and tracer transudation rate are reported, with statistics showing the quality of the results.




Primary Outcome Measures :
  1. Quantitative assessment of progress to euvolemic target for both subjects and controls [ Time Frame: Approximately 2 weeks ]
    Accurately quantify levels and changes to blood volume and red blood cell volume in ADHF inpatients during inpatient stay, and use this data to guide diuretic therapy in the treatment arm.


Secondary Outcome Measures :
  1. Quantitative assessment of event-based outcome metrics [ Time Frame: 30 days post discharge ]
    30-day readmission and mortality outcomes will be quantified for both cohorts.

  2. Quantitative assessment of continuous outcome metrics: weight [ Time Frame: Approximately 2 weeks ]
    Measure and compare changes to body weight in kilogram

  3. Quantitative assessment of continuous outcome metrics: net fluid balance [ Time Frame: Approximately 2 weeks ]
    Measure and compare changes to net fluid balance in mL

  4. Quantitative assessment of continuous outcome metrics: natriuretic peptide [ Time Frame: Approximately 2 weeks ]
    Measure and compare changes to natriuretic peptide in pg/mL



Information from the National Library of Medicine

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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:

  1. Age > 18 years. In accordance with the Inclusion Across the Lifespan policy, Children will be excluded from the proposed study. ADHF is a condition that rarely affects children and Daxor's BVA-100 lack the reference norms for pediatric use.
  2. Admission to the hospital with a primary diagnosis of ADHF.
  3. Able and willing to provide informed written consent.

Exclusion Criteria:

  1. Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.
  2. Evidence of hypertensive crisis or acute valvular regurgitation.
  3. The following has occurred within the last 3 months or is planned within the following 3 months:

    1. Revascularization procedure.
    2. Placement on cardiac transplantation list.
    3. Other major cardiac surgery or other surgery.
  4. Planned intermittent or continuous intravenous positive inotropic therapy.
  5. Severe chronic kidney disease (eGFR<15 ml/min).
  6. Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).
  7. Pregnant women or nursing mothers.
  8. Women of childbearing potential not using adequate birth control methods.
  9. Known hypersensitivity to iodine or eggs.
  10. Participation in another heart failure investigational treatment protocol currently or <30 days prior to enrollment.
  11. Evidence of active bleeding or active hemolysis.
  12. Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.
  13. Patient has received a heart transplant and/or currently treated with mechanical circulatory support.
  14. Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).

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): NCT04855097


Contacts
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Contact: Jonathan Feldschuh 9176091893 jafeldschuh@daxor.com

Locations
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United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Jacob Joseph, MD       JJOSEPH16@partners.org   
Sponsors and Collaborators
Daxor Corporation
VA Boston Healthcare System
Minneapolis Veterans Affairs Medical Center
Investigators
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Principal Investigator: Jacob Joseph Boston VA Healthcare System
Principal Investigator: Bradley Bart Minneapolis Veterans Affairs Medical Center
Principal Investigator: Orly Vardeny Minneapolis Veterans Affairs Medical Center
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Responsible Party: Daxor Corporation
ClinicalTrials.gov Identifier: NCT04855097    
Other Study ID Numbers: BVA for inpatient HF
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will primarily be captured from Clinical Report Forms and de-identified data will be transferred from the clinical sites to Daxor for analysis. All PHI used to abstract data will remain on the VA Health System servers and will not be transported outside for any research purpose. In accordance with VA policy, incident reporting of theft, loss of data, loss of storage media, unauthorized access to sensitive data or storage media and non-compliance with security controls will be reported promptly to the study PI, Privacy Officer and Information Security Officer.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available as collected throughout the study, and will be available for 18months prior to the completion of the study, for analysis.

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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
Keywords provided by Daxor Corporation:
Heart Failure
Blood Volume
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases