Heart Failure Clinical Trial

Monitoring Outpatient Blood VolumE in Heart Failure

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.

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Full 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.

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT04660396

Recruitment Status:

Completed

Sponsor:

Daxor Corporation

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There is 1 Location for this study

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Geisinger
Danville Pennsylvania, 17821, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT04660396

Recruitment Status:

Completed

Sponsor:


Daxor Corporation

How clear is this clinincal trial information?

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