Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure (TEAM-HF)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Daxor Blood Volume Analysis
Clinical volume status assessment
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Therapeutics, Blood volume
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
Sites / Locations
- Pacific Cardiology LLC
- Rush University Medical Center
- Baltimore VA Medical Center
- Valley Hospital
- New York University Langone Medical Center
- Columbia Presbyterian Medical Center
- St. Luke's Regional Heart Center-Bethlehem
- Temple University Hospital
- St. Thomas Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Daxor Blood Volume Analysis
Clinical volume status assessment
Arm Description
Subjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status.
Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.
Outcomes
Primary Outcome Measures
Hospitalization-free Survival
Secondary Outcome Measures
Cardiovascular mortality
Heart failure hospitalization
Quality of life questionnaire (KCCQ)
6 minute walk test
Hospitalization for worsening renal function
All cause hospitalization
All cause mortality
Full Information
NCT ID
NCT01001312
First Posted
October 22, 2009
Last Updated
October 8, 2015
Sponsor
NYU Langone Health
Collaborators
Daxor Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01001312
Brief Title
Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Acronym
TEAM-HF
Official Title
Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
Daxor Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Therapeutics, Blood volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daxor Blood Volume Analysis
Arm Type
Experimental
Arm Description
Subjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status.
Arm Title
Clinical volume status assessment
Arm Type
Active Comparator
Arm Description
Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.
Intervention Type
Other
Intervention Name(s)
Daxor Blood Volume Analysis
Intervention Description
Radiolabeled albumin for direct measurement of blood volume
Intervention Type
Other
Intervention Name(s)
Clinical volume status assessment
Intervention Description
Volume assessment based on history and physical examination
Primary Outcome Measure Information:
Title
Hospitalization-free Survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality
Time Frame
6 months
Title
Heart failure hospitalization
Time Frame
6 months
Title
Quality of life questionnaire (KCCQ)
Time Frame
6 months
Title
6 minute walk test
Time Frame
6 months
Title
Hospitalization for worsening renal function
Time Frame
6 months
Title
All cause hospitalization
Time Frame
6 months
Title
All cause mortality
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart D Katz, M.D.
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Cardiology LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
St. Luke's Regional Heart Center-Bethlehem
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashvilled
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
We'll reach out to this number within 24 hrs