CHF Solutions Clinical Results Presented at the Scientific Meeting of the Heart Failure Society of America.BROOKLYN PARK, Minn. -- Encouraging Results Stimulate Launch of Large Randomized Clinical Trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. Designed to Compare Company's Aquapheresis(TM) Therapy with Standard Fluid Removal Treatment Options CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. Solutions, Inc., a private medical device manufacturer, announced today that new findings from two clinical trials of Aquapheresis(TM), the company's therapy for fluid overload, were presented as posters at the recent Scientific Meeting of the Heart Failure Society of America (HFSA HFSA Heart Failure Society of America (also seen as HFSOA) HFSA Hungarian Financial Supervisory Authority HFSA Health Flexible Spending Account HFSA Hispanic Faculty Staff Association HFSA Health Flexible Spending Arrangement ) in Toronto, Canada. Data from the EUPHORIA trial at Midwest Heart Specialists, Chicago, and the RAPID CHF study, conducted by the Minnesota Heart Failure Consortium (MHFC MHFC Mt. Hope Family Center (Rochester, NY) ), Minneapolis, both demonstrated clear clinical benefits of Aquapheresis. Administered via CHF Solutions' Aquadex(TM) System 100, Aquapheresis is designed to safely and predictably remove excess fluid from fluid-overloaded patients. In heart failure patients, an inefficient heart can lead to a buildup of excess fluid, causing swollen legs and arms, fatigue, and eventually severe and life-threatening shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. . "These studies are important steps in broadening awareness of Aquapheresis as a treatment that can help the large and growing heart failure population," said John L. Erb, CHF Solutions president and chief executive officer. "We are pleased to see these studies confirm the efficacy of the Aquadex System 100 and are committing to expanding our knowledge of this therapy approach." "Both the EUPHORIA and RAPID CHF trial results add to the growing clinical evidence of the acute clinical benefits of fluid removal using Aquapheresis and support the sustained clinical benefits as seen in previous literature on ultrafiltration ultrafiltration /ul·tra·fil·tra·tion/ (ul?trah-fil-tra´shun) filtration through a filter capable of removing very minute (ultramicroscopic) particles. ul·tra·fil·tra·tion n. ," said Paul Sobotka, M.D., chief medical officer at CHF Solutions. "With next year's completion of our ongoing multi-center, prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. UNLOAD trial, we expect to confirm the benefits shown in smaller trials on a much wider scale." The EUPHORIA Trial - Midwest Heart Specialists The results of the EUPHORIA (Early Ultrafiltration Therapy in Patients with Decompensated Heart Failure and Observed Resistance to Interventions with Diuretic Agents) trial demonstrated that early treatment with the CHF Solutions Aquadex System 100 facilitated discharge of 68 percent of hospitalized patients admitted with acutely decompensated heart failure and diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying resistance in three days or less. These patients exhibited significant declines in brain natriuretic peptide Brain natriuretic peptide (also known as B-type natriuretic peptide or "GC-B") is a 32 amino acid polypeptide secreted by the ventricles of the heart in response to excessive stretching of myocytes (heart muscles cells) in the ventricles. (BNP BNP B-type natriuretic peptide, brain natriuretic peptide Physiology A 32-residue peptide hormone produced predominantly in the ventricles, secreted in response to fluid overload–eg, CHF. See Atrial natriuretic peptide. ) levels indicating decreased stress level of their hearts and improvement on the Quality Of Life and NYHA NYHA New York Heart Association (New York Heart Association) classification scales. In follow-up, none of the patients were readmitted within 30 days and only two admissions occurred within 90 days, one for elective pacemaker implantation and the other for dehydration associated with an incidental infection. "In the trial, this removal of large amounts of fluid was achieved without hypotension hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). , worsening renal failure or electrolytes abnormalities," said principal investigator of the EUPHORIA study, Maria Rosa Costanzo, M.D., Midwest Heart Specialists. "The beneficial neurohormonal and clinical changes of early Aquapheresis were sustained up to 90 days." The RAPID CHF Clinical Study - Minnesota Heart Failure Consortium The RAPID CHF (Relief for Acutely Fluid Overloaded PatIents with Decompensated Congestive Heart Failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. ) clinical trial is the first randomized trial of ultrafiltration therapy for acute heart failure patients ever performed. The results demonstrated that patients hospitalized for CHF treated with a single, eight-hour Aquapheresis session, in addition to standard medical therapy, achieved significantly greater volume removal 24 hours after enrollment compared to patients receiving standard medical therapy alone. "Our results show that Aquapheresis is feasible in a community-based hospital setting and is a safe and effective means of fluid removal in patients hospitalized with CHF," said Dr. Bradley Bart, principal investigator of the RAPID CHF study and director of Nuclear Cardiac Imaging at Hennepin County Medical Center Hennepin County Medical Center (HCMC) is a Level I trauma center based in Minneapolis, Minnesota, the county seat of Hennepin County. The primary 422-bed facility is located on five city blocks across the street from the Hubert H. , Minneapolis. The RAPID CHF study assessed several measures of clinical efficacy, including total weight loss, quality of life, level of CHF disease classification, length of hospital stay and blood chemistry changes before, during and 30 days after treatment. This study was conducted at six Minneapolis/St.Paul-based hospitals. The UNLOAD Trial - 20 Clinical Sites The UNLOAD (UltrafiltratioN versus IV Diuretics Diuretics Definition Diuretics are medicines that help reduce the amount of water in the body. Purpose Diuretics are used to treat the buildup of excess fluid in the body that occurs with some medical conditions such as congestive heart for Patients HospitaLized fOr Acute Decompensated Congestive Heart Failure) trial is comparing the long-term safety and efficacy of Aquapheresis to conventional intravenous diuretics in hospitalized heart failure patients with fluid overload. This trial will enroll 200 patients at as many as 20 U.S. clinical sites. CHF Solutions expects to announce UNLOAD trial results in the fourth quarter of 2005. About Aquapheresis(TM) and the Aquadex(TM) System 100 Aquapheresis, an advanced form of ultrafiltration, is a simple, transportable procedure that can be performed in virtually any clinical setting and remove up to four liters (one gallon) of excess fluid from the body in eight hours with no clinically significant impact on electrolytes, heart rate or blood chemistry. Performed by the Aquadex System 100, this procedure is highly automated and easy to use. Standard catheters inserted into peripheral or central veins connect the fluid-overloaded patient to the Aquadex System 100. Aquapheresis with the Aquadex System 100 technology received 510(k) marketing clearance from the Food and Drug Administration in June 2002 and is available commercially in the United States. About CHF Solutions CHF Solutions, based in Brooklyn Park, Minn., is a privately held manufacturer of innovative 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 additional information about CHF Solutions, Aquapheresis, and the Aquadex System 100, visit www.chfsolutions.com. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion