Pediatric Heart Disease Network: CHOP Membership

描述（由申请人提供） 作为一个新的儿科心脏病临床研究的临床中心 网络（PHDCRN），儿童？费城医院（CHOP） 与网络合作，改善儿童的成果 为目前使用的治疗方法提供证据基础， 考虑，开发新的疗法，并将这些信息传播给 医学界。为实现这一目标，我们将致力于实现以下目标： 目标1：建立一个基础设施和调查小组， 目标2：制定程序和政策， 正确实施已批准的PHDCRN方案;目标3：充分参与 在制定新的议定书和传播信息， 科学界。两个协议提出了PHDCRN？的科学 议程，强调心脏科的研究优势， 心脏中心和CHOP。短期研究调查了 双心室起搏或心脏起搏治疗重度 充血性心力衰竭和扩张型心肌病的主要目的 研究旨在评价双心室起搏对心脏的急性影响 在6周的运动中通过耗氧量测量功能 随机对照临床试验。经过6周的随机比较， 所有患者均为起搏，对心脏功能、功能 能力和生活质量将在12个月内进行评估。长期 项目调查依那普利（ACE抑制剂）是否可以减少与时间相关的 运动能力下降的患者经历的单一 接受Fontan手术的患者。主要目标是 评价ACE抑制剂在4年内对最大氧含量的影响 在一项双盲随机化研究中， 临床试验设计。孩子们？费城心脏病医院 科和心脏中心有着卓越的临床创新历史 和卓越的心脏护理，一个高容量的计划，在所有的专业知识 儿科心脏病学领域，包括心律失常，超声心动图， 运动生理学导管插入术，包括干预、重症监护， 心脏磁共振成像、心脏移植和心脏手术 疾病患者护理通过多学科心脏 中心心脏中心的教员都是经验丰富的研究人员， 保持高生产力的多中心和机构临床计划 试验和研究。CHOP在临床研究方面进行了大量投资 支持临床研究基本功能的基础设施。 这些方案和体制优势支持各项目标，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.