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

目的：正在研究的药物CP-424,391是一种生长激素(GH)释放肽模拟物，可显著增加年轻人和老年人GH的分泌。这项研究的主要目的是评估该药物的安全性，确定IGF-1中生长激素的水平，并评估轻至中度心力衰竭患者的心功能。方法：这是一项由辉瑞公司赞助的II期多中心临床试验。预计全国共有96名患者参加。到资助年度的最后一天，即1998年11月30日，只有一名患者在杜克大学登记。然而，截至本报告日期，杜克大学已有3名患者登记，全国共有8名病人登记。预计研究的完成日期为1999年8月。结果：目前还没有结果。意义：随着心肌梗死存活率的提高和人群平均寿命的延长，充血性心力衰竭可能成为工业化人群中最常见的心血管疾病。这与生长激素(GH)的治疗和一些缺血性心脏病的血浆危险因素的改善以及泵的性能有关。生长激素治疗产生血管外周扩张以及心脏收缩强度的改善，并伴随着心肌(心脏)质量的增加。这种疗法可能会增强心力衰竭患者的心功能。未来计划：目前还没有。

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.