The sponsor stopped this trial in October 1998. This was done when it became clear that projected enrollment would not be achieved within a reasonable time frame. Neither patients nor their physicians were willing to be randomized to surgery versus medicine. The purpose of this study was to determine if dynamic cardiomyoplasty would improve functional status and quality of life when compared with medical therapy in patients with dilated cardiomyopathy and heart failure. Dynamic cardiomyoplasty is a novel surgical treatment in which the latissimus dorsi is wrapped around the heart and stimulated to contract with a pacemaker-like device. The surgery was first done in 1985. Initial data suggested that this form of surgery improved quality of life and left ventricular function in patients with heart failure due to dilated cardiomyopathy. The current study was initiated over 3 years ago. In this multi-center, randomized, unblinded, clinical trial, patients with symptomatic heart failure (NYHA Class II-III) due to dilated cardiomyopathy were randomized to surgery or medical therapy. Follow-up was for one year with the possibility of crossover from medical therapy to dynamic cardiomyoplasty at that time. The primary end-point was quality of life and functional status at 12 months. One patient was enrolled in this trial at Johns Hopkins. He underwent dynamic cardiomyoplasty and did well. The sponsor stopped the trial on October 30, 1998. Analysis of the data is on going. Preliminary data suggests no statistical difference in patients treated with cardiomyoplasty when compared to continued medical therapy in terms of 6 minute walk distance, quality of life questionnaire, NYHA class, or peak oxygen consumption. We have not used GCRC resources for this trial in several years.
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