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Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure

NCT04855097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-29

No results posted yet for this study

Summary

Diuretic therapy is first-line treatment for acute decompensated heart failure. However, accurate assessment and management of patient blood volume is challenged by the limitations of physical exam and surrogate markers for blood volume. The study primary objective is to determine if goal-directed care as quantified by direct Blood Volume Analysis (Daxor BVA-100™) in addition to usual care results in more appropriate treatment and consistent achievement of euvolemia.

Conditions

  • Acute Decompensated Heart Failure

Interventions

DIAGNOSTIC_TEST

BVA-100

The BVA-100 is a medical device that calculates human blood volume using the method of tracer dilution. The device utilizes a tracer of human serum albumin tagged with iodine-131 to measure injected intravascularly and a series of timed blood draws. The amount of tracer in each blood draw is used to calculate the unknown blood volume. Data inputs come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and tracer transudation rate are reported, with statistics showing the quality of the results.

Sponsors & Collaborators

  • VA Boston Healthcare System

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • Daxor Corporation

    lead INDUSTRY

Principal Investigators

  • Jacob Joseph · Boston VA Healthcare System

  • Bradley Bart · Minneapolis Veterans Affairs Medical Center

  • Orly Vardeny · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855097 on ClinicalTrials.gov