Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure

Study Overview
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Brief Summary
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Heart failure is a common cardiac condition affecting nearly 6 million Americans. Silent blood volume overload is common in patients with heart failure and is associated with increased risk of death. This study is designed to determine if adjustment of therapy based on direct measurement of blood volume will reduce risk of hospitalization and death when compared with therapy based on clinical assessment of blood volume in patients with chronic heart failure.

Detailed Description
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Multicenter prospective randomized trial to compare heart failure management strategies based on clinical assessment of volume status vs. direct measurement of blood volume with a radioisotope technique. Subjects will be randomly assigned to a standard care strategy with guideline recommended treatment based on serial clinical assessment of blood volume or a measured blood volume strategy with guideline recommended treatment based on serial measured blood volume. All subjects will undergo blood volume measurement procedures, but the testing results will only be returned to the physician in the group assigned to management according to measured blood volume status. Subjects will be blinded to their study treatment assignment status.

Official Title
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Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Daxor Blood Volume Analysis
* Other: Clinical volume status assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >21 years Discharge from hospital or emergency department observation unit with a primary diagnosis of acute decompensated heart failure Planned discharge home Able and willing to provide informed consent Exclusion Criteria: Significant co-morbidity during heart failure hospitalization (treated pneumonia, sepsis, respiratory failure, oliguric renal failure, major bleeding requiring transfusion, stroke) Heart failure primarily due to significant valvular disease, sub-aortic outflow obstruction, active myocardial ischemia, apical ballooning syndrome, active arrhythmias, active myocarditis, primary restrictive cardiomyopathy, pericardial disease, or congenital heart disease Other major co-morbidities that increase mortality risk (stroke with hemiplegia, diabetes with end-organ damage other than heart disease, history of cancer in last 2 years, moderate to severe liver disease, HIV infection with AIDS) Hospitalization length of stay >10 days Evidence of acute coronary syndrome during qualifying heart failure hospitalization Planned revascularization procedure within 6 months Planned implantation of ICD or pacemaker within 6 months Planned placement on cardiac transplantation list within 6 months Planned other major cardiac surgery or other surgery within 6 months Planned intermittent or continuous intravenous positive inotropic therapy Planned intermittent or continuous intravenous vasodilator therapy Severe obesity (BMI ≥ 40 kg/m2) or cachexia (BMI ≤18 kg/m2) Severe chronic kidney disease (estimated GFR<30 ml/min (Modification of Diet in Renal Disease formula20)) Hemoglobin < 10 gm/dl Non-cardiac primary limitation to exercise (rheumatological, orthopedic, pulmonary, neurological or peripheral vascular disease) Known history of non-adherence with medications Psycho-social factors that interfere with ability to adhere to study procedures (dementia, active substance abuse, poorly controlled psychiatric illnesses, inability to travel frequently to the study center) Pregnant women or nursing mothers Women of childbearing potential not using adequate birth control methods Known hypersensitivity to iodine, eggs, or any other component of the Volumex injection kit History of anaphylaxis Participation in another heart failure investigational treatment protocol currently or <30 days

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daxor Blood Volume Analysis<br>Subjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status. | Other: Daxor Blood Volume Analysis<br>* Radiolabeled albumin for direct measurement of blood volume<br>|
| Active Comparator: Clinical volume status assessment<br>Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status. | Other: Clinical volume status assessment<br>* Volume assessment based on history and physical examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization-free Survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 6 months | 
| Heart failure hospitalization |  | 6 months | 
| Quality of life questionnaire (KCCQ) |  | 6 months | 
| 6 minute walk test |  | 6 months | 
| Hospitalization for worsening renal function |  | 6 months | 
| All cause hospitalization |  | 6 months | 
| All cause mortality |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Therapeutics, Blood volume