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Acute Decompensated Heart FailureNCT04855097

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

A study testing BVA-100 in people with Acute Decompensated Heart Failure, run by Daxor Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
BVA-100
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
1 May 2022to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Boston Healthcare System

    Boston, Massachusetts, 02130

Other trials in United States

About this study

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.

Read the 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.

Being tested
BVA-100
Keywords
Heart Failure, Blood Volume
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BVA-100Diagnostic test

    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.

Study groups in NCT04855097
Study groupRoleWhat they receive
Standard care groupExperimentalBlood 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.
Receives: Diagnostic Test: BVA-100
BVA-guided treatment armExperimentalBlood 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.
Receives: Diagnostic Test: BVA-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 2 weeks

Secondary outcomes (4)

  1. Quantitative assessment of event-based outcome metrics

    30-day readmission and mortality outcomes will be quantified for both cohorts.

    Measured: 30 days post discharge

  2. Quantitative assessment of continuous outcome metrics: weight

    Measure and compare changes to body weight in kilogram

    Measured: Approximately 2 weeks

  3. Quantitative assessment of continuous outcome metrics: net fluid balance

    Measure and compare changes to net fluid balance in mL

    Measured: Approximately 2 weeks

  4. Quantitative assessment of continuous outcome metrics: natriuretic peptide

    Measure and compare changes to natriuretic peptide in pg/mL

    Measured: Approximately 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start1 May 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, two-center, parallel design, interventional, single-blinded pilot study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855097
Sponsor's protocol ID
BVA for inpatient HF
Status last verified
Sep 2023
First submitted
16 Apr 2021
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing BVA-100 in people with Acute Decompensated Heart Failure, run by Daxor Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative assessment of progress to euvolemic target for both subjects and controls (time frame: Approximately 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04855097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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