Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure

Study Overview
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Brief Summary
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Researchers are trying learn more about how the heart and blood volume interact in subjects with heart failure and how measuring blood volume may help them develop better ways of treating and managing heart failure patients.

Official Title
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Pathophysiologic and Outcomes Impact of the Relation of Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure - Pathway to More Individualized Therapy

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Quantitated Blood Volume Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Decompensated Chronic Heart Failure, diagnosed clinically with volume overload by the primary Heart Failure provider or Emergency Department physician and admitted to hospital. New York Hear Association functional class III-IVa with stage C or D Heart Failure with Left Ventricular Ejection Fraction <50% Intended treatment plan with intravenous loop diuretic therapy during hospitalization Meeting none of the Exclusion Criteria Exclusion Criteria: Age < 18 years Having received any investigational drug or device within 30 days prior to entry into the study. Clinically unstable patients (e.g. systolic blood pressure < 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation). Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration. Prior organ transplantation or being on a waiting list for organ transplantation Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH). History of blood pressure > 190/115 mmHg or unexplained syncope within the past 3 months. Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months Clinically significant intrinsic renal disease (eGFR <15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries Baseline hemoglobin < 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal History of alcohol abuse within the past 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with heart failure<br>Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done | Diagnostic Test: Quantitated Blood Volume Analysis<br>* Measurement of total blood volume, composed of red blood cell mass (RBCM) and plasma volume (PV) by administering low dose iodinated I-131 labeled albumin intravenously then taking blood samples at timed increments.<br>* Other names: BVA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total blood volume | Measured in milliliters | Baseline, 1 month, 3 month, and 6 month | 
| Change in red blood cell volume | Measured in milliliters | Baseline, 1 month, 3 month, and 6 month | 
| Change in plasma volume | Measured in milliliters | Baseline, 1 month, 3 month, and 6 month |