Back to resultsEvaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Primary Purpose
Acute Decompensated Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BVA-100
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Heart Failure, Blood Volume
Eligibility Criteria
Inclusion Criteria:
- 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.
- Admission to the hospital with a primary diagnosis of ADHF.
- Able and willing to provide informed written consent.
Exclusion Criteria:
- Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.
- Evidence of hypertensive crisis or acute valvular regurgitation.
The following has occurred within the last 3 months or is planned within the following 3 months:
- Revascularization procedure.
- Placement on cardiac transplantation list.
- Other major cardiac surgery or other surgery.
- Planned intermittent or continuous intravenous positive inotropic therapy.
- Severe chronic kidney disease (eGFR<15 ml/min).
- Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods.
- Known hypersensitivity to iodine or eggs.
- Participation in another heart failure investigational treatment protocol currently or <30 days prior to enrollment.
- Evidence of active bleeding or active hemolysis.
- Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.
- Patient has received a heart transplant and/or currently treated with mechanical circulatory support.
- Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).
Sites / Locations
- VA Boston Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard care group
BVA-guided treatment arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quantitative assessment of event-based outcome metrics
30-day readmission and mortality outcomes will be quantified for both cohorts.
Quantitative assessment of continuous outcome metrics: weight
Measure and compare changes to body weight in kilogram
Quantitative assessment of continuous outcome metrics: net fluid balance
Measure and compare changes to net fluid balance in mL
Quantitative assessment of continuous outcome metrics: natriuretic peptide
Measure and compare changes to natriuretic peptide in pg/mL
Full Information
NCT ID
NCT04855097
First Posted
April 16, 2021
Last Updated
September 28, 2023
Sponsor
Daxor Corporation
Collaborators
VA Boston Healthcare System, Minneapolis Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04855097
Brief Title
Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Official Title
Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daxor Corporation
Collaborators
VA Boston Healthcare System, Minneapolis Veterans Affairs Medical Center
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Heart Failure, Blood Volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, two-center, parallel design, interventional, single-blinded pilot study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants and treating physicians will have no access to the BVA data in the Standard Care arm.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care group
Arm Type
Experimental
Arm Description
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.
Arm Title
BVA-guided treatment arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
BVA-100
Intervention Description
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 Measure Information:
Title
Quantitative assessment of progress to euvolemic target for both subjects and controls
Description
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
Secondary Outcome Measure Information:
Title
Quantitative assessment of event-based outcome metrics
Description
30-day readmission and mortality outcomes will be quantified for both cohorts.
Time Frame
30 days post discharge
Title
Quantitative assessment of continuous outcome metrics: weight
Description
Measure and compare changes to body weight in kilogram
Time Frame
Approximately 2 weeks
Title
Quantitative assessment of continuous outcome metrics: net fluid balance
Description
Measure and compare changes to net fluid balance in mL
Time Frame
Approximately 2 weeks
Title
Quantitative assessment of continuous outcome metrics: natriuretic peptide
Description
Measure and compare changes to natriuretic peptide in pg/mL
Time Frame
Approximately 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Admission to the hospital with a primary diagnosis of ADHF.
Able and willing to provide informed written consent.
Exclusion Criteria:
Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.
Evidence of hypertensive crisis or acute valvular regurgitation.
The following has occurred within the last 3 months or is planned within the following 3 months:
Revascularization procedure.
Placement on cardiac transplantation list.
Other major cardiac surgery or other surgery.
Planned intermittent or continuous intravenous positive inotropic therapy.
Severe chronic kidney disease (eGFR<15 ml/min).
Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).
Pregnant women or nursing mothers.
Women of childbearing potential not using adequate birth control methods.
Known hypersensitivity to iodine or eggs.
Participation in another heart failure investigational treatment protocol currently or <30 days prior to enrollment.
Evidence of active bleeding or active hemolysis.
Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.
Patient has received a heart transplant and/or currently treated with mechanical circulatory support.
Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Joseph
Organizational Affiliation
Boston VA Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Bart
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orly Vardeny
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
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