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

October 8, 2015 updated by: Stuart Katz, NYU Langone Health

Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pacific Cardiology LLC
    • Illinois
      • Chicago, Illinois, United States
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Regional Heart Center-Bethlehem
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Tennessee
      • Nashvilled, Tennessee, United States
        • St. Thomas Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization-free Survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 6 months
6 months
Cardiovascular mortality
Time Frame: 6 months
6 months
6 minute walk test
Time Frame: 6 months
6 months
Heart failure hospitalization
Time Frame: 6 months
6 months
Quality of life questionnaire (KCCQ)
Time Frame: 6 months
6 months
Hospitalization for worsening renal function
Time Frame: 6 months
6 months
All cause hospitalization
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Daxor Corporation

Investigators

  • Principal Investigator: Stuart D Katz, M.D., NYU School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 26, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H09-560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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