Congenital and acquired heart disease is a significant health problem in children worldwide and is responsible for considerable acute illness and disability throughout childhood. Research is needed to improve the outcomes and quality of life for children living with congenital and acquired heart disease. Single research centers acting alone encounter difficulties with conducting adequately powered clinical research studies due to small patient populations. Well-designed multicenter clinical research studies are needed. The purpose of this grant application is for Baylor College of Medicine (BCM)/Texas Children's Hospital (TCH) Heart Center to renew participation as a Clinical Research Center of the Pediatric Heart Network (PHN) sponsored by National Heart, Lung, and Blood Institute. The goal of the PHN is to evaluate therapeutic and management strategies for children and adults with congenital heart defects and for children with inflammatory heart disease, heart muscle disease, and arrhythmias through multicenter clinical research. BCM/TCH will support the goals of the PHN by pursuing the following specific aims: SA1) To work cooperatively within the PHN to provide scientific expertise and supervision in development of studies related to pediatric cardiovascular disease and adult congenital heart disease, to conduct such studies and disseminate results over the 7-year cycle; SA2) To utilize the robust and complex TCH patient population available for potential study enrollment in order to identify, enroll and retain participants in all multi-center cardiovascular clinical trials; SA3) To effectively and efficiently manage and communicate all necessary resources for optimal conduct and performance in order to support PHN studies as well as activities, both research and administrative; and SA4) To utilize BCM/TCH's unique and robust data integration capabilities to interface with a variety of cardiovascular databases and registries, both internal and external, in order to leverage and contribute to clinical research activities throughout the PHN. Baylor/TCH Heart Center has experienced multidisciplinary leadership in Cardiology, Cardiac Surgery, Cardiac Critical Care, and Cardiovascular Anesthesiology with a successful 5-year track record of participation as a PHN clinical research center. TCH has a large patient population having provided over 3.5 million patient encounters in FY2015. TCH is located in a diverse and fast-growing region with the U.S., which provides a diverse patient population. This is reflected in the Heart Center's diverse diagnoses undergoing over 913 cardiac operating room cases, 1,150 cardiac catheterizations, 27,746 echocardiograms, and currently following more than 900 patients (0 to +18 years) with single ventricle anatomy. With this clinical presence and capabilities in conjunction with a proven track record in participating in clinical research Baylor/TCH Heart Center proposes to continue to be a leading Clinical Research Center within the next 7-year cycle of the PHN.
Congenital and acquired heart disease is a significant health problem in children worldwide and is responsible for mortality and considerable acute illness and disability throughout childhood in survivors. The proposed research is relevant to public health because it will provide a mechanism for the development and conduct of scientifically rigorous, well powered clinical research studies, which will provide the evidence needed to guide clinical practice in congenital heart disease and pediatric acquired heart disease. This in turn will support the mission of National Heart, Lung and Blood Institute as it relates to reducing the burdens of heart diseases worldwide.