Daxor - Blood Volume Analysis

Heart Failure Clinical Trial

Official title:

Blood Volume Analysis - Guided Heart Failure Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111185
• Other study ID #: Pro00102851
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 23, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Daxor Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Whole Blood Volume		Baseline, and upon discharge (up to day 18)
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	Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
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	Baseline, day 1, day 2, day 3 and discharge (up to day 18)