The Duke-UNC-CH Pediatric Cardiology Clinical Center

杜克大学-北卡罗来纳大学-CH 儿科心脏病学临床中心

• 批准号: 6401228
• 负责人: Page A Anderson
• 金额: $ 45.47万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6401228
• 关键词: antihypertensive agents; arrhythmia; chemoprevention; child (0-11); clinical trials; congenital heart disorder; cooperative study; drug screening /evaluation; heart disorder chemotherapy; heart function; heart surgery; human morbidity; human subject; human therapy evaluation; methylprednisolone; patient oriented research; pediatric pharmacology; pediatrics; postoperative state; quality of life

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.

描述（由申请人提供） 杜克大学医学中心和北卡罗来纳州查珀尔大学 希尔医疗中心（UNC-CH）将在儿科成立一个临床中心 心脏病临床研究网络。杜克将是主要地点， UNC-CH子站点。这项合作的成功可能是 在各中心以前和目前的联合参与下， 多层次和多年。这些互动包括合作 在病人护理、研究生教育和联邦资助的临床 杜克和UNC-CH都是主要和子站点的研究。的 这些中心的长期研究项目已经研究了广泛的 与小儿心脏病相关的问题，包括 心肺转流（CPB）后综合征、心律失常的基础， 先天性心脏缺陷患者的心室功能改变， 心衰这些研究的范围从收缩蛋白到 患者的体内心脏，并检查了心律失常的治疗， 基于导管的器械植入，并测试 药理学药物每年，我们的联合方案有超过11，000 门诊就诊并进行超过600次心脏导管插入术，8，000次 超声心动图，200例电生理干预/消融，150例 基于导管的干预和490例儿科心脏外科手术。 拟开展的双盲随机对照试验为：长期研究 在Fontan患者中进行为期3年的卡维地洛疗效和安全性研究 心室功能降低;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 婴儿的综合征。卡维地洛试验的主要目的是 医生的临床总体评估。在患有心力衰竭的成年人中， 交感神经系统激活越强， 临床过程已发现卡维地洛可改善生活质量， 降低这些患者的死亡率。我们的试验将验证一个假设， 卡维地洛可改善糖尿病患者的生活质量、临床病程和射血分数 丰唐病人甲基强的松龙被广泛使用， 有效降低CPB后综合征的发病率。我们将测试 假设甲基强的松龙减少PICU停留时间，维持正常 血管通透性，防止肾和肝损伤，并改善 临床过程我们期待着参加该网络， 照顾患有先天性和后天性心脏病的婴儿和儿童。