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

随着心肌梗死生存率的提高和人口平均寿命的延长，充血性心力衰竭将有可能成为工业化人口中最普遍的心血管疾病。生长激素（GH）治疗与缺血性心脏病的一些血浆危险因素以及泵性能的改善有关。生长激素治疗产生外周血管扩张以及心脏收缩强度的改善，与心肌（心脏）质量增加有关。正在研究的药物CP-424,391是一种生长激素释放肽模拟物，可显著增加年轻人和老年人的生长激素分泌。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名患者入组。在这个资助年度，有6名白人男性患者参加了杜克大学CRU研究的第一部分。该研究的第一阶段是针对三个给药队列中每个队列的前8名患者。一旦对每个I段给药队列的数据进行分析，患者可以在门诊的基础上入组II段。赞助公司现在已经结束了I段部分的入组，因为每个级别有8名患者入组。他们一直在第二阶段继续登记，目前处于中等剂量范围。截至1999年11月30日，在全国范围内，共有64名患者入组，其中11名是女性，大约不到10名是少数民族。由于第一阶段的研究已经结束，我们将不再在GCRC中招募更多的患者。

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.