Monitoring Outpatient Blood VolumE in Heart Failure (MOVE-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: BVA-100

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Daxor Corporation
• Collaborators: Geisinger Clinic
• Investigators: Principal Investigator: Brendan Carry, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diuresis; Plasma Volume; Blood Volume; Red Blood Cell Volume
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MOVE-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No