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

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
Stuart Katz, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01001312
First received: October 22, 2009
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Heart Failure
Other: Daxor Blood Volume Analysis
Other: Clinical volume status assessment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Hospitalization-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Heart failure hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life questionnaire (KCCQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 6 minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hospitalization for worsening renal function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • All cause hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001312

Locations
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
Sponsors and Collaborators
New York University School of Medicine
Daxor Corporation
Investigators
Principal Investigator: Stuart D Katz, M.D. NYU School of Medicine
  More Information

No publications provided

Responsible Party: Stuart Katz, Principal Investigator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01001312     History of Changes
Other Study ID Numbers: H09-560
Study First Received: October 22, 2009
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Heart Failure
Therapeutics
Blood volume

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014