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Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure (TEAM-HF)

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
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
Stuart Katz, NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 26, 2009
Last Update Posted Date October 9, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Hospitalization-free Survival [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Official Title  ICMJE Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Other: Daxor Blood Volume Analysis
    Radiolabeled albumin for direct measurement of blood volume
  • Other: Clinical volume status assessment
    Volume assessment based on history and physical examination
Study Arms  ICMJE
  • 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.
    Intervention: Other: Daxor Blood Volume Analysis
  • Active Comparator: Clinical volume status assessment
    Subjects in this treatment arm will receive guideline recommended treatment based on clinical assessment of volume status.
    Intervention: Other: Clinical volume status assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2013)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
300
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001312
Other Study ID Numbers  ICMJE H09-560
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stuart Katz, NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Daxor Corporation
Investigators  ICMJE
Principal Investigator: Stuart D Katz, M.D. NYU School of Medicine
PRS Account NYU Langone Health
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP