NCT04111185

Daxor - Blood Volume Analysis

Blood Volume Analysis - Guided Heart Failure Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-16
• Primary completion: 2021-07-15
• Completion: 2021-09-23
• First posted: 2019-10-01
• Last updated: 2023-06-28
• Results posted: 2022-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study