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OpenTrials
Completed

NCT Number: NCT04660396

Monitoring Outpatient Blood VolumE in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger

Danville, Pennsylvania, 17821, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quantify volume shifts in post discharge heart failure patients

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Daxor Corporation

Industry

Collaborators

  • Geisinger Clinic

Registry information

Acronym: MOVE-HF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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