Monitoring Outpatient Blood VolumE in Heart Failure

NCT04660396 | Completed FDA Device

• 1 other identifier: MOVE-HF
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In patients discharged following heart failure treatment, the consistency of blood volume status and components over time is unknown. The primary objective is to describe the rate of change, if any, of the plasma volume and red blood cell volume following hospitalization and discharge of patients with heart failure.

Conditions

Heart Failure

Keywords

Plasma Volume; Red Blood Cell Volume; Blood Volume; Diuresis

Outcome Measures

Primary Outcomes (1)

• Quantify volume shifts in post discharge heart failure patients

  Accurately quantify changes to plasma volume and red blood cell volume in HF outpatients over the 12-week period following discharge.

  12 weeks

Study Arms (1)

Outpatients following discharge for treatment of heart failure

Daxor Corporation's commercially available Blood Volume Analyzer, BVA-100, will be performed at 5 timepoints for each patient.

Device: BVA-100

Interventions

BVA-100 DEVICE

The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in "131I -HSA"). Data inputs to the software 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 transudation rate are reported, with statistics showing the quality of the results. The subject blood samples and calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

Outpatients following discharge for treatment of heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to Geisinger Medical Center with a diagnosis of acute heart failure.

You may qualify if:

• Hospitalized male and female patients with primary or secondary admission diagnosis of acute heart failure exacerbation
• \> 18 years of age
• Able and willing to provide consent
• Reduced or preserved LVEF

You may not qualify if:

• Diagnosed with current acute strokes
• Pregnant women
• Severe hypotension requiring resuscitation, intubation or circulatory support
• Cardiogenic shock
• Patients with known cardiac amyloid and hypotension
• Known allergy to iodine or iodinated albumin

Sponsors & Collaborators

• Daxor Corporation: lead
• Geisinger Clinic: collaborator

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17821, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Brendan Carry

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: September 16, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)