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

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.

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