Johns Hopkins All Children's Hospital

Dr. Asante-Korang talks with Maddie, a heart transplant patient Outstanding Pediatric Heart Care JOHNS HOPKINS ALL CHILDREN'S HEART INSTITUTE has two internationally recognized pediatric heart surgeons who have performed more than 170 transplants for patients with congenital or acquired heart defects. "No two patients are the same," says pediatric transplant cardiologist Alfred Asante-Korang, M.D., F.A.C.C., who leads the medical management of patients before, during and after transplant. "After multiple catheterizations and echocardiograms, I am very familiar with a patient's particular cardiac defects before transplant and can help the surgeons understand the patient's unique heart structure and vasculature." 90% ONE-YEAR SURVIVAL RATE 82% FIVE-YEAR SURVIVAL RATE for pediatric heart transplant patients at Johns Hopkins All Children's Heart Institute Johns Hopkins All Children's Heart Institute—one of four multidisciplinary institutes that collaborate routinely—is a national leader in pediatric cardiovascular care on many fronts. Some highlights appear on the next few pages. JOHNS HOPKINS ALL CHILDREN'S HOSPITAL will provide one of three principal investigators in a National Institutes of Health grant to leverage existing registry resources to facilitate clinical trials. e aim of this study is to use existing data in a clinical registry—data that was gathered in the registry as surgeries were conducted—to carry out simple, efficient and low-cost clinical trials in understudied patient populations, such as neonates undergoing heart surgery. e hope is that this approach will accelerate putting new and optimal treatment approaches into clinical practice. e study will design and conduct a "trial within a registry" to evaluate safety and effectiveness of perioperative steroids for neonatal cardiopulmonary bypass surgery. At the same time, researchers at Johns Hopkins All Children's and other participating hospitals will develop infrastructure for a registry- based pediatric heart surgery trials network and define a new model for cost-effective clinical trials that can be used to study other diseases and conditions. "is trial will be the largest ever in neonates with congenital heart defects, will be conducted at a fraction of the cost of a traditional prospective, randomized trial, and will answer a clinical question that has persisted for decades," says Jeffrey P. Jacobs, M.D., F.A.C.S., F.A.C.C., F.C.C.P., professor of surgery and pediatrics at Johns Hopkins University School of Medicine and chief of the division of cardiovascular surgery, and codirector of the Heart Institute. "By proving that researchers can conduct a randomized trial within a clinical registry, this study could change the way research is done." NIH-funded 'Trial Within a Registry' Defining New Research Model Heart Transplant Expertise Winter 2017 13 Heart Institute

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