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

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Purpose: The drug under study, CP-424,391 is a growth-hormone (GH)-releasing peptide mimetic that significantly augments GH secretion in young and elderly humans. The primary aims of the study are to evaluate the safety of the drug, to determine the levels of growth hormones in IGF-1, and to evaluate cardiac function in patients with mild-to moderate heart failure. Methods: 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. Only one patient was enrolled at Duke by the last day of the funding year, November 30, 1998. However, as of the date of this report there have been 3 patients enrolled at Duke, for a total of 8 enrolled throughout the country. The projected date of study completion is August, 1999. Results: There are no results available at this time. Significance: 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. This therapy may enhance cardiac function in patients with heart failure. Future plans:There are none at this time.