Pediatric Heart Disease Network: CHOP Membership

描述(由申请人提供) 作为临床中心的新型儿科心脏病临床研究 费城S儿童医院(CHOP)将 与该网络协作参与，改善儿童的成果 对于心脏病，为目前使用的治疗方法提供证据基础或 考虑，开发新的治疗方法，并将信息传播给 医学界。为实现这一目标，我们将实现以下目标： 目标1：建立基础设施和调查团队，以确保充分 参与PHDCRN；目标2：制定程序和政策以确保 适当执行经批准的PHDCRN协议；目标3：充分参与 在制定新的议定书和向 科学界。为PHDCRN提出了两个协议--S科学 强调心脏科的研究优势的议程， 心脏中心和印章。这项短期研究调查了 双室起搏或心脏再同步化治疗重症儿童 充血性心力衰竭和扩张型心肌病。该计划的主要目标是 评价双室起搏对心脏功能的急性影响 通过在6周的运动中耗氧量来衡量功能 随机对照临床试验。经过6周的随机比较后， 所有患者都进行了起搏，并对心功能、功能有较长期的影响 能力和生活质量将被评估为12个月。长期的 该项目调查依那普利(ACE抑制)是否可以减少与时间相关的 单项运动障碍患者的运动能力下降 接受过丰坦手术的脑室。其主要目标将是 评价血管紧张素转换酶抑制4年来对最大氧量的影响 双盲随机抽样调查运动试验中的消耗量 临床试验设计。儿童？费城S心脏病医院 科室和心脏中心拥有卓越的临床创新历史 和卓越的心脏护理，这是一个在所有领域都有专业知识的高容量计划 儿科心脏病学领域包括心律失常，超声心动图， 运动生理学导尿术，包括干预，重症监护， 心脏磁共振成像、心脏移植和心脏外科 疾病。通过多学科的心脏护理整合患者护理 中心。心脏中心的教职员工都是经验丰富的研究人员和 维持多中心和机构临床的高效计划 试验和研究。CHOP在临床研究方面进行了重大投资 支持临床研究中基本功能的基础设施。 这些方案和体制优势支持这些目标并加强 实现PHDCRN长期目标的可能性。

DESCRIPTION (provided by applicant) As a Clinical Center in the new Pediatric Heart Disease Clinical Research Network (PHDCRN), the Children?s Hospital of Philadelphia (CHOP) will participate collaboratively with the Network to improve outcomes for children with heart disease, provide an evidential base for therapies currently used or considered, develop new therapies, and disseminate that information to the medical community. To achieve this goal, we will address the following aims: Aim 1: Develop an infrastructure and investigational team for to assure full participation in PHDCRN; Aim 2: Develop procedures and policies to assure proper implementation of approved PHDCRN protocols; Aim 3: Fully participate in the development new protocols and dissemination of information to the scientific community. Two protocols are proposed for the PHDCRN?s scientific agenda that emphasize the research strengths of the Cardiology Division, the Cardiac Center and CHOP. The short-term study investigates the use of biventricular pacing or cardiac resynchronization in children with severe congestive heart failure and dilated cardiomyopathy. The primary aim of the study is to evaluate the acute effects of biventricular pacing on cardiac function as measured by oxygen consumption during exercise in a 6-week randomized controlled clinical trial. After the 6-week randomized comparison, all patients are paced and longer-term effects on cardiac function, functional capacity and quality of life will be evaluated out to 12 months. The long-term project investigates whether enalapril (ACE inhibition) can reduce the time-related decline in exercise performance experienced by patients with single ventricle who have undergone the Fontan procedure. The primary aim will be to evaluate the effects of ACE inhibition over a 4-year period on maximal oxygen consumption measured during exercise testing in a double blinded randomized clinical trial design. The Children?s Hospital of Philadelphia Cardiology Division and Cardiac Center has a distinguished history of clinical innovation and excellence in cardiac care, a high volume program with expertise in all areas of pediatric cardiology including cardiac arrhythmias, echocardiography, exercise physiology catheterization including interventions, intensive care, cardiac magnetic resonance imaging, transplantation, and surgery for heart disease. Patient care is integrated through a multidisciplinary Cardiac Center. The faculty of the Cardiac Center are experienced investigators and maintain a highly productive program of multicenter and institutional clinical trials and studies. CHOP has made major investments in the clinical research infrastructure that support essential functions in clinical investigations. These programmatic and institutional strengths support the aims and enhance the likelihood that the long-term goals of the PHDCRN will be achieved.