Heart FailureNCT06227819
BVA-200 vs BVA-100 Validation Study
An observational study of Heart Failure and High Blood Pressure, run by Daxor Corporation at 1 site in United States.
Trial summary
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, High Blood Pressure, High Cholesterol
- What is being tested?
- BVA-200
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 30 Nov 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The proposed study will be open to any volunteer meeting the inclusion/exclusion criteria listed below. We intend to highlight differential analysis of clinical patients from exemplary disease states (such as congestive heart failure and chronic kidney disease), as well as other population characteristics such as age, sex, race, etc.
Who may be able to join
- Age: Over18 years;
- Able and willing to provide informed written consent.
- Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study.
Who cannot join
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods.
- Known hypersensitivity to iodine or eggs.
- Other clinical basis for precluding the use of radioactive materials.
- Has previously been enrolled in, and completed, the study.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.
Read the detailed description
Measurements of human blood volume will be made via the indicator dilution method, using gamma counter readings of the concentration of I-131 in a subject's blood sample taken after radio-iodinated Human Serum Albumin (HSA) has been injected into the bloodstream via venous access. Each subject receiving an injection will have five separate blood samples taken, which will be analyzed separately. Each of the five measurements will be conducted in duplicate with the BVA-100 instrument and the BVA-200 instrument. Sufficient blood will be withdrawn at each phlebotomy to permit such duplicate measurement.
Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study. An effort will be made to ensure a range of ages and a balance of the sexes.
Subjects will be enrolled and consented sequentially. The University of Tennessee Medical Center site will document any patient who is not enrolled in the study sequentially and the reason why or who declines enrollment. Demographics of patients not enrolled will be collected to permit identification of any trends in non-enrollment. We do not anticipate any sequential patient not being offered the opportunity to participate in order to assure that there is no bias in selection of patients ("all-comers").
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia, Diabetes, Thyroid Diseases
- Being tested
- BVA-200
- Keywords
- Blood volume, Point of care, Fluid management, Diagnostic
- Medical subject headings
- Heart Failure, Hypertension, Hypercholesterolemia, Anemia, Diabetes Mellitus, Thyroid Diseases, Kidney Diseases, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVA-200Diagnostic test
Blood samples collected for measurement with the BVA-100 will also be tested with the BVA-200. The BVA-200 uses whole blood collection cartridges which allow for a precise amount of blood to be measured without the need to first centrifuge and then pipette plasma aliquots. A small amount of whole blood from each sample will be set aside for BVA-200 use, while the remainder of the blood sample is used for BVA-100 measurement. The BVA-200 device was developed with the support of the Department of Defense through Phase I (W81XWH19C0048) and Phase II (W81XWH20C0025) SBIR contracts.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish equivalence of BVA-200 to BVA-100
Comparison of a sufficient number of indicator-dilution volume measurements between BVA-100 and BVA-200 devices to establish substantial equivalence.
Measured: Approximately 6 months.
Secondary outcomes (3)
Establish equivalence of BVA-200 to BVA-100 in TBV, RCV, PV and ATR
Comparison of a sufficient number of full 5-point time-zero blood volume measurements between BVA-100 and BVA-200 devices, to establish substantial equivalence, including measurement of:
- Total Blood Volume (TBV)
- Red Cell Volume (RCV)
- Plasma Volume (PV)
- Albumin transudation rate (ATR)
Measured: Approximately 6 months.
Filling consistency validation
Validation of filling consistency of at least 100 whole blood quantitative collection cartridges, in at least 40 sets of 5 samples from the same patient
Measured: Approximately 6 months.
Usability
Validation of the ability of personnel who are not laboratorians to understand the test procedures and perform the measurement after receiving training materials (which may be a combination of written instructions, video instructions, and individual instruction) in the use of the instrument. Usability is evaluated through a User Validation Survey consisting of yes or no questions, as well as questions answered on a scale of 1 (strongly disagree) to 5 (strongly agree), where 5 is the most favorable outcome.
Measured: Approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start23 May 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daxor Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stern Cardiovascular Foundation, Inc., Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Jonathan Feldschuh, Principal investigator, Daxor Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227819
- Sponsor's protocol ID
- BVA-200 Validation
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BVA-200 vs BVA-100 Validation Study
- ClinicalTrials.gov ID
- NCT06227819
- Acronym / sponsor ID
- BVA-200 Validation
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia, Diabetes, Thyroid Diseases
- Keywords
- Blood volume, Point of care, Fluid management, Diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Daxor CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Stern Cardiovascular Foundation, Inc., Oregon Health and Science University
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.
Detailed description
Measurements of human blood volume will be made via the indicator dilution method, using gamma counter readings of the concentration of I-131 in a subject's blood sample taken after radio-iodinated Human Serum Albumin (HSA) has been injected into the bloodstream via venous access. Each subject receiving an injection will have five separate blood samples taken, which will be analyzed separately. Each of the five measurements will be conducted in duplicate with the BVA-100 instrument and the BVA-200 instrument. Sufficient blood will be withdrawn at each phlebotomy to permit such duplicate measurement.
Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study. An effort will be made to ensure a range of ages and a balance of the sexes.
Subjects will be enrolled and consented sequentially. The University of Tennessee Medical Center site will document any patient who is not enrolled in the study sequentially and the reason why or who declines enrollment. Demographics of patients not enrolled will be collected to permit identification of any trends in non-enrollment. We do not anticipate any sequential patient not being offered the opportunity to participate in order to assure that there is no bias in selection of patients ("all-comers").
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The proposed study will be open to any volunteer meeting the inclusion/exclusion criteria listed below. We intend to highlight differential analysis of clinical patients from exemplary disease states (such as congestive heart failure and chronic kidney disease), as well as other population characteristics such as age, sex, race, etc.
Key inclusion criteria (3 listed)
- Age: Over18 years;
- Able and willing to provide informed written consent.
- Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study.
Key exclusion criteria (5 listed)
- Pregnant women or nursing mothers.
- Women of childbearing potential not using adequate birth control methods.
- Known hypersensitivity to iodine or eggs.
- Other clinical basis for precluding the use of radioactive materials.
- Has previously been enrolled in, and completed, the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVA-200Blood samples collected for measurement with the BVA-100 will also be tested with the BVA-200. The BVA-200 uses whole blood collection cartridges which allow for a precise amount of blood to be measured without the need to first centrifuge and then pipette plasma aliquots. A small amount of whole blood from each sample will be set aside for BVA-200 use, while the remainder of the blood sample is used for BVA-100 measurement. The BVA-200 device was developed with the support of the Department of Defense through Phase I (W81XWH19C0048) and Phase II (W81XWH20C0025) SBIR contracts. | Diagnostic test | – |
Primary outcome
Establish equivalence of BVA-200 to BVA-100
Time frame: Approximately 6 months.
Comparison of a sufficient number of indicator-dilution volume measurements between BVA-100 and BVA-200 devices to establish substantial equivalence.
3 secondary outcomes
Establish equivalence of BVA-200 to BVA-100 in TBV, RCV, PV and ATR
Time frame: Approximately 6 months.
Filling consistency validation
Time frame: Approximately 6 months.
Usability
Time frame: Approximately 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
Related trials for Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Feldschuh principal investigator
Daxor Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and High Blood Pressure, 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 5 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 Jan 2024. 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?
Establish equivalence of BVA-200 to BVA-100 (time frame: Approximately 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.