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Completed

NCT Number: NCT04111185

Daxor - Blood Volume Analysis

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Congestive Heart Failure Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Receive Blood Volume Analysis Guided Treatment

Device

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

Other names: Daxor BVA-100

Primary outcomes

  1. Change in Whole Blood Volume

    Time frame: Baseline, and upon discharge (up to day 18)

Secondary outcomes

  1. Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

    Comparison of baseline to follow up times

  2. Change in Mean NTpro-BNP Concentration (in pg/mL)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

  3. Change in Weight (in kg)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

  4. Change in Renal Function as Measured by Creatinine (mg/dL)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

  5. Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

    Comparison of baseline to follow up times

  6. Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

    Comparison of baseline to follow up times

  7. Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)

    Time frame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)

    Comparison of baseline to follow up times

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Daxor Corporation

Registry information

Official study title

Blood Volume Analysis - Guided Heart Failure Management

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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