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

随着心肌梗死存活率的提高和人群平均寿命的增加，充血性心力衰竭将潜在地成为工业化人群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某些血浆风险因素以及泵性能的改善有关。 GH治疗产生血管的外周扩张以及心脏收缩强度的改善，与心肌（心脏）质量增加相关。 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GH分泌。 这是一项由辉瑞公司申办的II期多中心临床试验。 预计全国共入组96例患者。 在本资助年度，6例白色男性患者入组杜克CRU研究的I阶段部分。 研究的第I阶段部分针对三个给药队列中每个队列的前8例患者。 一旦分析了每个第一阶段给药队列的数据，患者就可以门诊入组第二阶段部分。 申办公司现已结束I阶段部分的入组，因为每个水平入组了8例患者。 他们一直在继续入组第II阶段，目前处于中等剂量范围。 截至1999年11月30日，在全国范围内，这两个部分共招募了64名患者，其中11名为女性，约不到10名为少数民族。 由于I阶段部分已关闭，我们将不会在GCRC中招募更多患者参与本研究。

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.