PH II: CP 424,391 FOR MILD TO MODERATE HEART FAILURE

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With improvement in survival of myocardial infarction, and with an increase in the average life span of the population, congestive heart failure will potentially become the most prevalent cardiovascular disease in the industrialized population. There has been a link to treatment with growth hormone (GH) and improvement in some plasma risk factors for ischemic heart disease as well as pump performance. GH therapy produces a peripheral dilation of blood vessels as well as an improvement in the strength of contraction of the heart, in association with increased myocardial (heart) mass. The drug under study, CP-424,391 is a growth-hormone-releasing peptide mimetic that significantly augments GH secretion in young and elderly humans. This is a phase II multicenter clinical trial sponsored by Pfizer, Inc. A total of 96 patients are expected to be enrolled throughout the country. There were 6 white, male patients enrolled in the Segment I portion of the study in the Duke CRU during this funding year. The Segment I portion of the study is for the first 8 patients of each of three dosing cohorts. Patients may be enrolled into the Segment II portion on an out-patient basis once data is analyzed for each of the Segment I dosing cohorts. The sponsoring company has now ended enrollment into the Segment I portion since 8 patients have been enrolled at each level. They have been continuing to enroll in Segment II, and are currently at the mid-level dosing range. Nationwide in both Segments, there have been 64 patients enrolled by 11/30/99, 11 of whom are female, and approximately less than 10 are minorities. Since the Segment I portion is closed, we will not be enrolling any more patients for this study in the GCRC.