Monitoring Outpatient Blood VolumE in Heart Failure

NCT ID: NCT04660396

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2022-07-30

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.

Detailed Description

Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases. High 30-day readmission and mortality rates have persisted despite advances in care. Clinical guidelines suggest blood volume assessment and clinical management to euvolemia or normal blood volume, but standard methods of blood volume diagnosis have been shown to be unreliable. FDA-cleared Blood volume analysis (BVA) has been used to quantify otherwise undiagnosed blood volume derangements in heart failure and other indications. Also, care guided by BVA has been demonstrated to improve inpatient heart failure readmission and mortality. A similar analysis has not previously been performed immediately following hospital discharge, though this period is understood to be challenging due to high variability of patient status, physiology, and compliance.

This is a prospective, single-center, observational open-label study. The primary objective is to quantify changes to plasma volume and red blood cell volume over a 12 week period post-discharge.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BVA-100

Intervention Type: 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.

Interventions

BVA-100

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: collaborator

Daxor Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan Carry

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger

Danville, Pennsylvania, United States

Countries

United States

Other Identifiers

MOVE-HF

Identifier Type: -

Identifier Source: org_study_id