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Beta-blocker evaluation of survival trial (BEST)

$648M01FY2000RRNIH

Virginia Commonwealth University, Richmond VA

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Abstract

The examination of the medication bucindodol and how it effects congestive heart failure. Congestive heart failure (CHF), a condition where the heart becomes enlarged and does not empty blood as well as it would normally, is a major public health problem in the United States. This syndrome effects 1% of the U.S. population and 10% of patients over the age of 75. The incidence of CHF is steadily increasing. Treatment for this syndrome is unsatisfactory, with transplant patients being severely limited by the number of donors. Practical mechanical replacement seems unlikely in the near future. For these reasons, therapy with drugs remains the mainstay of treatment for most patients. There have been studies on the effectiveness of beta-blockers, a medication that has been used to treat heart pains, high blood pressure, fast heart rhythms, migraine headaches, and congestive heart failure. Bucindodol is one of these medications and has been found to block both beta-1 and beta-2 receptors. Data has suggested that beta-blockers improve the condition of CHF and have reduced the number of visits to the emergency room and hospitalizations. But, a definitive study is needed to determine the role of beta-blockers in altering survival of patients with CHF. The study will involve 30-40 patients with heart failure, possibly an equal number of men and women. Patients will have blood laboratory values done, scans, chest x-rays, and quality of life questionnaires will be completed. Then patients will be randomly entered into a medication group or a placebo group. All patients will continue to receive their standard medications for heart failure and any other medications they may be taking out of necessity. There will be periodic visits to the clinic for the next one and a half to four years to evaluate the patient health on the assigned drug. There will be a visit to the heart failure clinic once a week for the first six weeks and then once again six weeks later. Thereafter, they will be evaluated at three months and every six months during the duration of the four years. On three of the visits, blood will be drawn. A medical nuclear scan will be done to show the strength of the heart. Chest x-rays and electrocardiograms will be done three times. Questionnaires about the quality of life will be done at follow-up visits.

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