Monitoring Outpatient Blood VolumE in Heart Failure

Heart Failure Clinical Trial

— MOVE-HF  

Official title:

Monitoring Outpatient Blood VolumE in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660396
• Other study ID #: MOVE-HF
• Status: Completed
• Start date: September 16, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2023
• Source: Daxor Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Daxor Corporation	Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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