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National Institutes of Health Begins Study of CHF Solutions' Aquapheresis(TM) Therapy

Posted on: Tuesday, 2 September 2008, 09:00 CDT

The National Institutes of Health (NIH) has informed CHF Solutions, Inc. that the CARRESS-HF trial has begun enrolling patients. Sponsored by NIH's National Heart, Lung, and Blood Institute and chosen out of 16 national submissions for studies in heart failure, this study will compare CHF Solutions' unique Aquapheresis therapy with standard medical drug therapy in patients hospitalized with acute decompensated heart failure (ADHF) and cardiorenal syndrome.

The CARdiorenal REScue Study in Acute Decompensated Heart Failure, or CARRESS-HF study, is open to NIH centers and is a randomized, multi-center, 200- patient trial that is testing if Aquapheresis therapy in hospitalized ADHF patients with cardiorenal syndrome results in improved renal function and relief of congestion compared to stepped pharmacologic care. It is estimated that CardioRenal syndrome occurs in 25 percent of the millions of hospitalized Acute Heart Failure (AHF) patients each year.

"I believe that CARRESS is a very important trial," describes Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine at Harvard Medical School. "I look forward to the results which can have an important impact on the care of seriously ill patients with heart failure."

Duke University is the data coordinating center for the trial. Participating are nine Regional Heart Failure Consortiums comprising more than 25 medical centers throughout the United States and Canada. Some of these centers include: Brigham and Women's Hospital, Mayo Clinic, Minnesota Heart Failure Network, Duke University Medical Center, Baylor College of Medicine, University of Utah, University of Vermont, and the Montreal Heart Institute. Detailed information about the study can be found at the U.S. National Institutes of Health Clinical Trials website at the following address: http://clinicaltrial.gov/ct2/show/NCT00608491?term=CARRESS

About Heart Failure and CardioRenal Syndrome

Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress (known as cardiorenal syndrome) is a common complication of heart failure and the drug based therapies used to treat it. Further medical problems and the need for hospitalization are currently common outcomes. While there are various treatments for heart failure, research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome.

About Fluid Overload and Aquapheresis(TM)

Fluid overload can be caused by problems with the heart, kidneys, liver and lungs, and is frequently experienced after surgical operations, trauma, and burns. The leading cause of fluid overload is congestive heart failure (CHF), sometimes referred as just heart failure. Heart failure is a condition that affects approximately 5 million Americans and is responsible for over 3.1 million primary and secondary hospitalizations annually.

CHF Solutions' Aquapheresis therapy is a mechanical method to safely and effectively remove the excess salt and water in patients with fluid overload. Aquapheresis is currently available at more than 250 leading medical centers and outpatient clinics worldwide. To date, over 15,000 patients have received therapy.

About CHF Solutions

CHF Solutions, based in Brooklyn Park, Minn., is a privately held manufacturer of medical devices for cardiac care. The company's mission is to provide medical practitioners with innovative and practical solutions that enable the treatment of patients with unmet clinical needs. For more information, go to www.chfsolutions.com and www.unloadstudy.com.

Source: Business Wire

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