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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Radiolabeled albumin for direct measurement of blood volume
Volume assessment based on history and physical examination
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
Hospitalization-free Survival
Time frame: 6 months
Cardiovascular mortality
Time frame: 6 months
Heart failure hospitalization
Time frame: 6 months
Quality of life questionnaire (KCCQ)
Time frame: 6 months
6 minute walk test
Time frame: 6 months
Hospitalization for worsening renal function
Time frame: 6 months
All cause hospitalization
Time frame: 6 months
All cause mortality
Time frame: 6 months
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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