The Duke-UNC-CH Pediatric Cardiology Clinical Center

描述(由申请人提供) 杜克大学医学中心和北卡罗来纳大学教堂分校 希尔医疗中心(UNC-CH)将在儿科建立一个临床中心 心脏病临床研究网络。杜克大学将成为主要地点 UNC-CH子站点。这一提议的协作可能取得的成功是 由各中心以前和正在进行的共同参与提供支持 多层次、多年限。这些交互包括协作 在病人护理、研究生教育和联邦政府资助的临床 杜克大学和北卡罗来纳大学-CH都是主要和次要站点的研究。这个 这些中心的长期研究项目研究了广泛的 与儿童心脏病有关的问题，包括病理生理学 体外循环(CPB)后综合征、心律失常和 先天性心脏病患者的心功能改变 心力衰竭。研究的范围从收缩蛋白到In 患者的活体心脏，并检查了心律失常的治疗， 以导管为基础的装置植入，并测试疗效和安全性 药理药物。每年我们加在一起的项目超过11,000个 门诊就诊和进行的心导管手术超过600次，8000次 超声心动图，200次电生理干预/消融，150次 以导管为基础的介入治疗和490例儿科心脏外科手术。 建议的双盲随机对照试验为：长期研究 卡维地洛治疗方坦患者的三年疗效和安全性 一项为期两年的短期研究， 甲基强的松龙预防体外循环术后并发症的疗效和安全性 婴儿的综合症。卡维地洛试验的主要目的是 由医生进行的临床全球评估。在患有心力衰竭的成年人中， 交感神经系统激活程度越大，病情越差 临床课程。卡维地洛已被发现可以改善生活质量和 降低这些患者的死亡率。我们的试验将检验这一假设 卡维地洛改善患者的生活质量、临床病程和射血分数 方坦的病人。甲基强的松龙被广泛使用，并被认为是 能有效降低体外循环术后综合征的发生率。我们将测试 甲基强的松龙减少PICU停留时间，维持正常的假设 血管通透性，防止肾脏和肝脏损害，并改善 临床课程。我们期待着参与到网络中来，提高 先天性和获得性心脏病婴儿和儿童的护理。

DESCRIPTION (provided by applicant) Duke University Medical Center and the University of North Carolina at Chapel Hill Medical Center (UNC-CH) will form a Clinical Center in the Pediatric Heart Disease Clinical Research Network. Duke will be the primary site and UNC-CH the subsite. The likely success of this proposed collaboration is supported by the previous and ongoing joint participation by the Centers at multiple levels and over many years. These interactions include collaborations in patient care, post-graduate education, and federally funded clinical research in which Duke and UNC-CH have both been primary and subsites. The longstanding research programs at the centers have studied a broad range of issues relevant to pediatric heart disease, including the pathophysiologic basis of the post-cardiopulmonary bypass (CPB) syndrome, dysrhythmias, and altered ventricular function in patients with congenital cardiac defects and heart failure. The studies have ranged from the contractile proteins to the in vivo heart of the patient and have examined the treatment of dysrhythmias, catheter-based device implantation, and testing the efficacy and safety of pharmacologic drugs. Annually our combined programs have over 11,000 outpatient visits and perform in excess of 600 cardiac catheterizations, 8,000 echocardiograms, 200 electrophysiological interventions/ablations, 150 catheter-based interventions, and 490 pediatric cardiac surgical procedures. The proposed double blind randomized controlled trials are: a long-term study of three years duration, carvedilol efficacy and safety in the Fontan patient with depressed ventricular function; a short-term study of two years duration, the efficacy and safety of methylprednisolone in preventing the post-CPB syndrome in the infant. The primary objective of the carvedilol trial is the Clinical Global Assessment by the physician. In the adult with heart failure, greater sympathetic nervous system activation is associated with worse clinical course. Carvedilol has been found to improve quality of life and decrease mortality in these patients. Our trial will test the hypothesis that carvedilol improves quality of life, clinical course, and ejection fraction in the Fontan patient. Methylprednisolone is widely used and thought to be efficacious in decreasing the morbidity of the post-CPB syndrome. We will test the hypothesis that methylprednisolone decreases PICU stay, maintains normal vascular permeability, prevents renal and hepatic damage, and improves the clinical course. We look forward to participating in the Network and improving the care of infants and children with congenital and acquired heart disease.