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| Name | Class |
|---|---|
| Daxor Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whole Blood Volume | Baseline, and upon discharge (up to day 18) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
| Change in Mean NTpro-BNP Concentration (in pg/mL) |
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Inclusion Criteria:
- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Michael Felker, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Receive Blood Volume Analysis Guided Treatment | The health care team will be provided with BVA (blood volume analysis) results and may use the information to make decisions regarding the participant's treatment. Receive Blood Volume Analysis Guided Treatment: 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 |
| FG001 | Receive Standard of Care 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receive Blood Volume Analysis Guided Treatment | The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment. Receive Blood Volume Analysis Guided Treatment: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Whole Blood Volume | Posted | Mean | Standard Deviation | mL | Baseline, and upon discharge (up to day 18) |
|
Up to 18 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receive Blood Volume Analysis Guided Treatment | The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment. Receive Blood Volume Analysis Guided Treatment: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marat Fudim, MD, MHS | Duke University | 919-684-1284 | marat.fudim@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2020 | Jul 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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) | 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) | 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 | 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 | 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 | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
| BG001 | Receive Standard of Care 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | 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 | Data not collected. | Posted | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
|
|
| Secondary | Change in Mean NTpro-BNP Concentration (in pg/mL) | Posted | Mean | Standard Deviation | pg/mL | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge |
|
|
|
| Secondary | Change in Weight (in kg) | Posted | Mean | Standard Deviation | kg | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge |
|
|
|
| Secondary | Change in Renal Function as Measured by Creatinine (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge |
|
|
|
| Secondary | Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL) | Comparison of baseline to follow up times | Data not collected. | Posted | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
|
|
| Secondary | Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2) | Comparison of baseline to follow up times | Data not collected. | Posted | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
|
|
| Secondary | 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 | Data not collected. | Posted | Baseline, day 1, day 2, day 3 and discharge (up to day 18) |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Receive Standard of Care 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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