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

NYU Langone Health

Status and phase

Terminated

Phase 4

Conditions

Heart Failure

Treatments

Other: Daxor Blood Volume Analysis

Other: Clinical volume status assessment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01001312

H09-560

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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