Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure (TEAM-HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01001312 |
Recruitment Status :
Terminated
(Poor enrollment)
First Posted : October 26, 2009
Last Update Posted : October 9, 2015
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure | Other: Daxor Blood Volume Analysis Other: Clinical volume status assessment | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Daxor Blood Volume Analysis
Subjects in this treatment arm will receive guideline recommended treatment based on direct blood volume measurement for assessment of volume status.
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Other: Daxor Blood Volume Analysis
Radiolabeled albumin for direct measurement of blood volume |
Active Comparator: Clinical volume status assessment
Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.
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Other: Clinical volume status assessment
Volume assessment based on history and physical examination |
- 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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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001312
United States, Hawaii | |
Pacific Cardiology LLC | |
Honolulu, Hawaii, United States, 96813 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States | |
United States, Maryland | |
Baltimore VA Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, New Jersey | |
Valley Hospital | |
Ridgewood, New Jersey, United States, 07450 | |
United States, New York | |
New York University Langone Medical Center | |
New York, New York, United States, 10016 | |
Columbia Presbyterian Medical Center | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
St. Luke's Regional Heart Center-Bethlehem | |
Bethlehem, Pennsylvania, United States, 18015 | |
Temple University Hospital | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Tennessee | |
St. Thomas Research Institute | |
Nashvilled, Tennessee, United States |
Principal Investigator: | Stuart D Katz, M.D. | NYU School of Medicine |
Responsible Party: | Stuart Katz, Principal Investigator, NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT01001312 |
Other Study ID Numbers: |
H09-560 |
First Posted: | October 26, 2009 Key Record Dates |
Last Update Posted: | October 9, 2015 |
Last Verified: | October 2015 |
Heart Failure Therapeutics Blood volume |
Heart Failure Heart Diseases Cardiovascular Diseases |