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

Stopped early · Phase 4

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT01001312
Run by: NYU Langone Health
People needed: 22
Starts: 2010-10-01
Expected to finish: 2013-06-01
Last updated by the study team: 2015-10-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Pacific Cardiology LLC — Honolulu, Hawaii, United States
Rush University Medical Center — Chicago, Illinois, United States
Baltimore VA Medical Center — Baltimore, Maryland, United States
Valley Hospital — Ridgewood, New Jersey, United States
New York University Langone Medical Center — New York, New York, United States
Columbia Presbyterian Medical Center — New York, New York, United States
St. Luke's Regional Heart Center-Bethlehem — Bethlehem, Pennsylvania, United States
Temple University Hospital — Philadelphia, Pennsylvania, United States
St. Thomas Research Institute — Nashvilled, Tennessee, United States

Full record on ClinicalTrials.gov

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