Congestive Heart Failure, Heart Failure
Conditions
Brief 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.
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.
Interventions
DEVICEReceive 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
Sponsors
Daxor Corporation
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Whole Blood Volume | Baseline, and upon discharge (up to day 18) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean NTpro-BNP Concentration (in pg/mL) | 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 Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND) | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | Comparison of baseline to follow up times |
| Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2) | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | Comparison of baseline to follow up times |
| Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values) | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | Comparison of baseline to follow up times |
| Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL) | Baseline, day 1, day 2, day 3 and discharge (up to day 18) | Comparison of baseline to follow up times |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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. | 14 |
| Total | 31 |
Baseline characteristics
| Characteristic | Receive Blood Volume Analysis Guided Treatment | Total | Receive Standard of Care Treatment |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 32 | 61 years STANDARD_DEVIATION 31 | 60 years STANDARD_DEVIATION 30 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 31 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 14 |
| other Total, other adverse events | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 |
Outcome results
Primary
Change in Whole Blood Volume
Time frame: Baseline, and upon discharge (up to day 18)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Change in Whole Blood Volume | -1253 mL | Standard Deviation 2157 |
| Receive Standard of Care Treatment | Change in Whole Blood Volume | -784 mL | Standard Deviation 981 |
p-value: >0.05t-test, 2 sided
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
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Population: Data not collected.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Change in Mean NTpro-BNP Concentration (in pg/mL) | -853 pg/mL | Standard Deviation 3154 |
| Receive Standard of Care Treatment | Change in Mean NTpro-BNP Concentration (in pg/mL) | -4849 pg/mL | Standard Deviation 6770 |
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
Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Population: Data not collected.
Secondary
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)
Population: Data not collected.
Secondary
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)
Population: Data not collected.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Change in Renal Function as Measured by Creatinine (mg/dL) | 0.1 mg/dL | Standard Deviation 0.3 |
| Receive Standard of Care Treatment | Change in Renal Function as Measured by Creatinine (mg/dL) | 0.2 mg/dL | Standard Deviation 0.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Blood Volume Analysis Guided Treatment | Change in Weight (in kg) | -6.4 kg | Standard Deviation 5.4 |
| Receive Standard of Care Treatment | Change in Weight (in kg) | -10.1 kg | Standard Deviation 10.6 |