TEAM-HF: Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| 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. |
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. |
Other: Clinical volume status assessment
Volume assessment based on history and physical examination
|
Outcome Measures
Primary Outcome Measures
- Hospitalization-free Survival [6 months]
Secondary Outcome Measures
- 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]
- All cause hospitalization [6 months]
- All cause mortality [6 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Cardiology LLC | Honolulu | Hawaii | United States | 96813 |
| 2 | Rush University Medical Center | Chicago | Illinois | United States | |
| 3 | Baltimore VA Medical Center | Baltimore | Maryland | United States | 21201 |
| 4 | Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 5 | New York University Langone Medical Center | New York | New York | United States | 10016 |
| 6 | Columbia Presbyterian Medical Center | New York | New York | United States | 10032 |
| 7 | St. Luke's Regional Heart Center-Bethlehem | Bethlehem | Pennsylvania | United States | 18015 |
| 8 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 9 | St. Thomas Research Institute | Nashvilled | Tennessee | United States |
Sponsors and Collaborators
- NYU Langone Health
- Daxor Corporation
Investigators
- Principal Investigator: Stuart D Katz, M.D., NYU School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H09-560