Monitoring Outpatient Blood VolumE in Heart Failure

Completed

• Conditions: Heart Failure
• Interventions: Device: BVA-100

• Registration Number: NCT04660396
• Lead Sponsor: Daxor Corporation

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.

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Study Start: 2021-09-16
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatients following discharge for treatment of heart failure	BVA-100	Daxor Corporation's commercially available Blood Volume Analyzer, BVA-100, will be performed at 5 timepoints for each patient.

Primary Outcome Measures

Name	Time	Method
Quantify volume shifts in post discharge heart failure patients	12 weeks	Accurately quantify changes to plasma volume and red blood cell volume in HF outpatients over the 12-week period following discharge.

Trial Locations

Locations (1)

Geisinger; 🇺🇸 Danville, Pennsylvania, United States