Clinical trial NCT04111185: Daxor - Blood Volume Analysis
Official title: Blood Volume Analysis - Guided Heart Failure Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Congestive Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Daxor Corporation
First posted: 2019-10-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Whole Blood Volume
timeFrame: Baseline, and upon discharge (up to day 18)
Secondary outcomes:
measure: Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
measure: Change in Mean NTpro-BNP Concentration (in pg/mL)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
measure: Change in Weight (in kg)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
measure: Change in Renal Function as Measured by Creatinine (mg/dL)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge
measure: Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
measure: Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
measure: Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)
timeFrame: Baseline, day 1, day 2, day 3 and discharge (up to day 18)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: G. Michael Felker, MD
role: PRINCIPAL_INVESTIGATOR
References: