Daxor - Blood Volume Analysis

Duke University

Status: Completed

Conditions: Heart Failure; Congestive Heart Failure

Treatments: Device: Receive Blood Volume Analysis Guided Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04111185

Pro00102851

Details and patient eligibility

About

The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Receive Blood Volume Analysis Guided Treatment

Experimental group

Description:

The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.

Treatment:

Device: Receive Blood Volume Analysis Guided Treatment

Receive Standard of Care Treatment

No Intervention group

Description:

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.