N/A
Completed N=31
Daxor - Blood Volume Analysis
Source: ClinicalTrials.gov NCT04111185 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Change in Whole Blood Volume — -1253; -784 mL — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Whole Blood Volume |
-1253; -784 | >0.05 |
| SECONDARY Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND) |
— | — |
| SECONDARY Change in Mean NTpro-BNP Concentration (in pg/mL) |
-853; -4849 | — |
| SECONDARY Change in Weight (in kg) |
-6.4; -10.1 | — |
| SECONDARY Change in Renal Function as Measured by Creatinine (mg/dL) |
0.1; 0.2 | — |
| SECONDARY Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL) |
— | — |
| SECONDARY Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2) |
— | — |
| 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) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04111185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.