Daxor Corporation announced the undertaking of the TEAM-HF multi-center heart failure treatment clinical study.
The Treatment to Euvolemia (normal blood volume) by Assessment and Measured Blood Volume in Heart Failure or TEAM-HF study protocol is a multi-center prospective randomized trial to compare heart failure management strategies based on the current standard of clinical assessment of a patient’s blood volume status versus the direct blood volume measurement through the use of Daxor’s Blood Volume Analyzer BVA-100. The objectives of TEAM-HF are to determine the decrease of re-hospitalizations, all cause mortalities, cardiovascular mortalities and any improvement in the exercise capacity and quality of life in patients being treated for heart failure when a blood volume analysis is incorporated in their standard diagnosis and treatment. Leading heart failure diagnostic and treatment centers in New York, NY, Pittsburgh, PA, Winston-Salem, NC and Honolulu, HI have already confirmed their participation.
Daxor’s BVA-100 is the only FDA approved instrument which accurately measures a patients volume status. Recent published studies from Columbia Presbyterian Medical Center have demonstrated that the assessment of a patients blood volume status is only correct 51% of the time compared to a measured blood volume analysis. The Heart Failure Society of America states that clinical experience suggests it is difficult to determine that congestion has been adequately treated in many patients.
It is our hope that this 300 patient study involving at least 9 medical centers will demonstrate the clinical utility of a blood volume analysis in the treatment of heart failure patients, noted Daxor’s Chief Scientific Officer and CEO, Dr. Joseph Feldschuh. Dr. Feldschuh noted that Previous studies have shown that heart failure patients who have been treated to a normal blood volume, as determined by the BVA-100, had a 100% survival rate over a two year period versus patients who remained volume overloaded who had a 55% death rate. These early published findings are extremely significant, especially since hospitals are now losing their reimbursement for repeated hospitalizations within a 30-day period for the treatment of heart failure.
Unpublished studies from two heart failure centers have shown that some heart failure patients cannot be treated by medications alone, but also require adjunct therapies such as phlebotomy, the removal of excess blood. Therapeutic phlebotomy was once a mainstay for the treatment of heart failure, but is currently only used in limited instances. A Blood Volume Analysis (BVA) can identify which patients may be compromised by inappropriate medical treatments and which would benefit from the removal of excess blood. Without a BVA it is extremely difficult to identify patients who may be anemic and would be harmed from the removal of blood by phlebotomy. The current administration’s efforts to improve the efficiency of medical treatments are consistent with the main goals of the TEAM-HF study. If it can be determined that a BVA leads to more appropriate treatments and better outcomes, the BVA-100 may become a standard of care in heart failure.
The TEAM-HF study is anticipated to begin sometime within the third quarter of 2009 and will complete its enrollment and study of patients within 12 months.