SOURCE: Daxor Corporation

Daxor Corporation

February 16, 2011 08:30 ET

Daxor Corporation Announces Launch of Multicenter Research Study to Investigate Whether Direct Blood Volume Measurement Leads to Improved Outcomes in Heart Failure Patients

NEW YORK, NY--(Marketwire - February 16, 2011) - Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced the launch of a multicenter research study to investigate whether the use of direct blood volume measurement in addition to existing standards of care will lead to improved outcomes in heart failure patients. Daxor Corporation manufactures the Blood Volume Analyzer (BVA-100), which is the only FDA approved semi-automated instrument which accurately measures a patient's volume status.

The American Heart Association estimates that about 5 million people nationwide suffer from heart failure, which causes over 300,000 deaths each year. Heart failure is a life-threatening condition in which the heart muscle has been weakened and fails to maintain adequate blood flow to the body's tissues and organs. The most common causes of heart failure are hypertension and coronary heart disease. In 2008, the total estimated cost of heart failure treatment in the United States was $37.2 billion, which represents 1-2% of all healthcare expenditures. 

The Treatment to Euvolemia (normal blood volume) by Assessment and Measured Blood Volume in Heart Failure Study (referred to as the "TEAM-HF" Study) is a multi-center, prospective, randomized trial to compare heart failure management strategies based on the current standard of care versus data obtained from direct blood volume measurement obtained with Daxor's BVA-100. The objectives of the TEAM-HF Study are to determine whether incorporating blood volume measurement into a patient's care results in a reduction in hospitalization and mortality and an improvement in exercise capacity and quality of life. Currently, patients hospitalized for decompensated heart failure show almost 12% mortality at 30 days and a 20% hospital readmission rate at 30 days. 300 patients with acute decompensated heart failure will be enrolled into this study at the time of hospital discharge. Treatment for half of the patients will be based upon the results of a standard clinical assessment. Treatment for the other half of the patients will be based upon the results of direct blood volume measurement utilizing Daxor's BVA-100. All patients will be followed for a period of 6 months. 

The current Heart Failure Society of America, American College of Cardiology and American Heart Association treatment goals and practice guideline recommendations emphasize that it is critical to evaluate blood volume status and, if necessary, to initiate treatment to restore the blood volume to normal. The current standard of care relies solely on signs and symptoms, along with various surrogate laboratory tests, to estimate a patient's blood volume status. These surrogate measures are often inaccurate. Published studies from the Columbia Presbyterian Medical Center have shown that physicians' impression of a patient's blood volume status based on surrogate measures is correct only 51% of the time when compared to data obtained from direct measurement of blood volume (Am J Cardiol. 2004; 93:1254-9). 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." 

Dr. Stuart Katz, the Director of the Heart Failure Program at the NYU Langone Medical Center and the Helen L. and Martin S. Kimmel Professor of Advanced Cardiac Therapeutics, will serve as the National Principal Investigator for this study. Dr. Katz has conducted several previous single-center studies of blood volume in heart failure patients. In one study, he and his colleagues showed that heart failure patients with normal blood volumes showed 100% survival over a 2-year period, in contrast to heart failure patients with volume overload, who showed only a 45% survival rate over the same time period (Am J Cardiol. 2004; 93:1254-9). This pioneering research laid the groundwork for the TEAM-HF Study. 

The following thirteen hospitals and Principal Investigators are participating in the TEAM-HF Study:

  • NYU Langone Medical Center (NY) -- Dr. Alex Reyentovich
  • Columbia-Presbyterian Medical Center (NY) -- Dr. Mathew S. Maurer
  • Christiana Care Health System (DE) -- Dr. Mitchell T. Saltzberg
  • Allegheny General Hospital (PA) -- Dr. George S. Sokos
  • Pacific Cardiology LLC (HI) -- Dr. Gregg Yamada
  • St. Luke's Regional Heart Center (PA) -- Dr. Darren Traub and Dr. Prasanna Sugathan
  • Temple University Hospital (PA) -- Dr. James Fitzpatrick and Dr. Lazaros Nikolaidis
  • The Valley Hospital (NJ) -- Dr. John E. Strobeck
  • Rush University Medical Center (IL) -- Dr. Barbara Pisani and Dr. Jose Mendez
  • VA Maryland Health Care System (MD) -- Dr. Stephen S. Gottlieb
  • St. Thomas Heart (TN) -- Beth Davidson, DNP, RN, ACNP, CCRN
  • St. Joseph's Regional Medical Center (NJ) -- Dr. Robert Faillace
  • Hartford Hospital (CT) -- Dr. Detlef Wencker

The first patient was enrolled into the study by Dr. Mathew Maurer and his clinical research team at the Columbia-Presbyterian Medical Center in New York City. 

Dr. Joseph Feldschuh, the Chief Scientific Officer of Daxor Corporation, stated that: "It is our hope that this study will demonstrate the clinical utility of a blood volume analysis in the treatment of heart failure patients. The most important aspect of this study will be to see whether or not blood volume assessment can save lives. In addition, if it can be shown that hospital admissions are reduced by incorporating blood volume analysis into the treatment plan, this may have important implications for lowering hospital and medical costs. This is particularly important at a time when Medicare has proposed not to provide hospital insurance reimbursement for heart failure patients who return to the hospital within 30 days of a previous discharge. If it can be proven that blood volume analysis leads to reductions in mortality and hospital admission, then blood volume testing may become the standard of care in heart failure." 

For further information about this study please consult the Clinical Trials website at: http://clinicaltrials.gov/ct2/show/NCT01001312?term=team-hf&rank=1 or contact Sandra Gilbert at 212-330-8532.

Daxor Corporation manufactures and markets the BVA-100, which is used in conjunction with Volumex, Daxor's single use diagnostic kit. For more information regarding Daxor Corporation's Blood Volume Analyzer BVA-100, visit Daxor's website at www.Daxor.com.

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