Clinical trial NCT01001312: Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Official title: Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure
Therapeutics
Blood volume
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Daxor Corporation
First posted: 2009-10-26
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization-free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 6 months
measure: Heart failure hospitalization
timeFrame: 6 months
measure: Quality of life questionnaire (KCCQ)
timeFrame: 6 months
measure: 6 minute walk test
timeFrame: 6 months
measure: Hospitalization for worsening renal function
timeFrame: 6 months
measure: All cause hospitalization
timeFrame: 6 months
measure: All cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Pacific Cardiology LLC
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Bethlehem
country: United States
facility: St. Luke's Regional Heart Center-Bethlehem
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashvilled
country: United States
facility: St. Thomas Research Institute
state: Tennessee
Study officials:
affiliation: NYU School of Medicine
name: Stuart D Katz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: