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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Daxor Blood Volume Analysis

Subjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status.

Group Type EXPERIMENTAL

Daxor Blood Volume Analysis

Intervention Type OTHER

Radiolabeled albumin for direct measurement of blood volume

Clinical volume status assessment

Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.

Group Type ACTIVE_COMPARATOR

Clinical volume status assessment

Intervention Type OTHER

Volume assessment based on history and physical examination

Interventions

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Daxor Blood Volume Analysis

Radiolabeled albumin for direct measurement of blood volume

Intervention Type OTHER

Clinical volume status assessment

Volume assessment based on history and physical examination

Intervention Type OTHER

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No