An interventional study of Receive Blood Volume Analysis Guided Treatment in Heart Failure and Congestive Heart Failure, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 31 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
Exclusion Criteria:
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Device: Receive Blood Volume Analysis Guided Treatment
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.
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
Also known as: Daxor BVA-100
Change in Whole Blood Volume
Time frame: Baseline, and upon discharge (up to day 18)
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
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)
Comparison of baseline to follow up times
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)
Comparison of baseline to follow up times
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)
Comparison of baseline to follow up times
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
| Milestone | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment |
|---|---|---|
| Started | 17 | 14 |
| Completed | 17 | 14 |
| Not completed | 0 | 0 |
| mL | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment |
|---|---|---|
| Change in Whole Blood Volume | -1253 ± 2157 | -784 ± 981 |
Comparison of baseline to follow up times
No measurements were reported for this outcome.
| pg/mL | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment |
|---|---|---|
| Change in Mean NTpro-BNP Concentration (in pg/mL) | -853 ± 3154 | -4849 ± 6770 |
| kg | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment |
|---|---|---|
| Change in Weight (in kg) | -6.4 ± 5.4 | -10.1 ± 10.6 |
| mg/dL | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment |
|---|---|---|
| Change in Renal Function as Measured by Creatinine (mg/dL) | 0.1 ± 0.3 | 0.2 ± 0.3 |
Comparison of baseline to follow up times
No measurements were reported for this outcome.
Comparison of baseline to follow up times
No measurements were reported for this outcome.
Comparison of baseline to follow up times
No measurements were reported for this outcome.
Collected over Up to 18 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Receive Standard of Care Treatment | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment | Total |
|---|---|---|---|
| Mean | 62 ± 32 | 60 ± 30 | 61 ± 31 |
| Sex: Female, Male(Participants) | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 12 | 11 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 17 | 14 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 8 | 17 |
| White | 8 | 6 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Receive Blood Volume Analysis Guided Treatment | Receive Standard of Care Treatment | Total |
|---|---|---|---|
| United States | 17 | 14 | 31 |
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