An interventional study of BVA-100 in Acute Decompensated Heart Failure, sponsored by Daxor Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Daxor Corporation · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 32 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Daxor Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The following has occurred within the last 3 months or is planned within the following 3 months:
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
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.
Quantitative assessment of progress to euvolemic target for both subjects and controls
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.
Time frame: Approximately 2 weeks
Quantitative assessment of event-based outcome metrics
30-day readmission and mortality outcomes will be quantified for both cohorts.
Time frame: 30 days post discharge
Quantitative assessment of continuous outcome metrics: weight
Measure and compare changes to body weight in kilogram
Time frame: Approximately 2 weeks
Quantitative assessment of continuous outcome metrics: net fluid balance
Measure and compare changes to net fluid balance in mL
Time frame: Approximately 2 weeks
Quantitative assessment of continuous outcome metrics: natriuretic peptide
Measure and compare changes to natriuretic peptide in pg/mL
Time frame: Approximately 2 weeks
Plan to share: Yes — 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 information: Csr
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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