Monitoring Outpatient Blood VolumE in Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Daxor Corporation
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Quantify volume shifts in post discharge heart failure patients
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.