Heart FailureNCT04111185
Daxor - Blood Volume Analysis
A study testing Receive Blood Volume Analysis Guided Treatment in people with Heart Failure and Congestive Heart Failure, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure
- What is being tested?
- Receive Blood Volume Analysis Guided Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
Who cannot join
- Age < 18 years
- Ongoing pregnancy
- Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days
- Post heart transplantation or ongoing mechanical circulatory support
- Progressive cardiogenic shock
- Patients with Ventricular Assist Devices
- End stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Volume Analysis - Guided Heart Failure Management
The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.
Read the detailed description
The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.
- Conditions
- Heart Failure, Congestive Heart Failure
- Being tested
- Receive Blood Volume Analysis Guided Treatment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive Blood Volume Analysis Guided TreatmentDevice
Also called Daxor BVA-100
The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
| Study group | Role | What they receive |
|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Experimental | The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment. Receives: Device: Receive Blood Volume Analysis Guided Treatment |
| Receive Standard of Care Treatment | No intervention | The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Whole Blood Volume
Measured: Baseline, and upon discharge (up to day 18)
Secondary outcomes (7)
Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)
Comparison of baseline to follow up times
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Mean NTpro-BNP Concentration (in pg/mL)
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Weight (in kg)
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Renal Function as Measured by Creatinine (mg/dL)
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)
Comparison of baseline to follow up times
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)
Comparison of baseline to follow up times
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)
Comparison of baseline to follow up times
Measured: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start16 Jul 2020
- Primary completion15 Jul 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Daxor Corporation
- Responsible party
- Sponsor
- Investigators
- G. Michael Felker, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111185
- Sponsor's protocol ID
- Pro00102851
- Status last verified
- Jun 2023
- First submitted
- 23 Sep 2019
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume Analysis - Guided Heart Failure Management
- ClinicalTrials.gov ID
- NCT04111185
- Acronym / sponsor ID
- Pro00102851
- Conditions
- Heart Failure, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Daxor Corporation
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.
Detailed description
The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Experimental | Device: Receive Blood Volume Analysis Guided TreatmentThe health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment. |
| Receive Standard of Care Treatment | No intervention | –The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
Key exclusion criteria (7 listed)
- Age < 18 years
- Ongoing pregnancy
- Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days
- Post heart transplantation or ongoing mechanical circulatory support
- Progressive cardiogenic shock
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 |
|---|---|---|
| Receive Blood Volume Analysis Guided TreatmentAlso: Daxor BVA-100The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis | Device | Receive Blood Volume Analysis Guided Treatment |
Primary outcome
Change in Whole Blood Volume
Time frame: Baseline, and upon discharge (up to day 18)
7 secondary outcomes
Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Mean NTpro-BNP Concentration (in pg/mL)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Weight (in kg)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Renal Function as Measured by Creatinine (mg/dL)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
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Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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.
G. Michael Felker, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive Blood Volume Analysis Guided Treatment in people with Heart Failure and Congestive Heart Failure, run by Duke University 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 1 inclusion and 7 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 28 Jun 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?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Whole Blood Volume (time frame: Baseline, and upon discharge (up to day 18)). 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 28 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.