Study Stopped
Poor enrollment
Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
TEAM-HF
Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure
1 other identifier
interventional
22
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started Oct 2010
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 9, 2015
October 1, 2015
2.4 years
October 22, 2009
October 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization-free Survival
6 months
Secondary Outcomes (7)
Cardiovascular mortality
6 months
Heart failure hospitalization
6 months
Quality of life questionnaire (KCCQ)
6 months
6 minute walk test
6 months
Hospitalization for worsening renal function
6 months
- +2 more secondary outcomes
Study Arms (2)
Daxor Blood Volume Analysis
EXPERIMENTALSubjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status.
Clinical volume status assessment
ACTIVE COMPARATORSubjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.
Interventions
Radiolabeled albumin for direct measurement of blood volume
Volume assessment based on history and physical examination
Eligibility Criteria
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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Daxor Corporationcollaborator
Study Sites (9)
Pacific Cardiology LLC
Honolulu, Hawaii, 96813, United States
Rush University Medical Center
Chicago, Illinois, United States
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
St. Luke's Regional Heart Center-Bethlehem
Bethlehem, Pennsylvania, 18015, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
St. Thomas Research Institute
Nashvilled, Tennessee, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart D Katz, M.D.
NYU School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2009
First Posted
October 26, 2009
Study Start
October 1, 2010
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
October 9, 2015
Record last verified: 2015-10