N/A N=31 Randomized Double-blind Treatment

Daxor - Blood Volume Analysis

Heart Failure · Congestive Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT04111185 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Change in Whole Blood Volume — -1253; -784 mL — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Receive Blood Volume Analysis Guided Treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2021

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)	—	—

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.

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

View full record on ClinicalTrials.gov →

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.