Daxor - Blood Volume Analysis

Not Applicable

Completed

• Conditions: Heart Failure; Congestive Heart Failure
• Interventions: Device: Receive Blood Volume Analysis Guided Treatment

• Registration Number: NCT04111185
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Study Start: 2020-07-16
• Primary Completion: 2021-07-15
• Study Completion: 2021-09-23
• Results First Submitted: 2022-07-08
• Results First Submitted QC: 2022-09-02
• Results First Posted: 2022-09-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receive Blood Volume Analysis Guided Treatment	Receive Blood Volume Analysis Guided Treatment	The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.

Primary Outcome Measures

Name	Time	Method
Change in Whole Blood Volume	Baseline, and upon discharge (up to day 18)

Secondary Outcome Measures

Name	Time	Method
Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)	Baseline, day 1, day 2, day 3 and discharge (up to day 18)	Comparison of baseline to follow up times
Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)	Baseline, day 1, day 2, day 3 and discharge (up to day 18)	Comparison of baseline to follow up times
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
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
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
Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)	Baseline, day 1, day 2, day 3 and discharge (up to day 18)	Comparison of baseline to follow up times
Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)	Baseline, day 1, day 2, day 3 and discharge (up to day 18)	Comparison of baseline to follow up times

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States