Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure (TEAM-HF)

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