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Cardiology

Pediatric Heart Network

The Division of Cardiology is one of eight clinical research centers for the Pediatric Heart Research Network (PHN), an important NIH-sponsored multi-center network with the overall goal of evaluating new and existing treatments and management approaches for children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, and arrhythmias.

The major ongoing projects of the PHN include the following:

• Marfan Trial -- a randomized trial of beta blocker therapy (atenolol) vs. angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome. The primary outcome is rate of change in aortic root (sinuses of Valsalva) size, as measured by body surface area-adjusted Z-score. Contact: Wyman W. Lai, MD, MPH
• Single Ventricle Reconstruction -- a Phase III, randomized trial of the RV-to-PA shunt vs. modified Blalock-Taussig shunt of patients with hypoplastic left heart syndrome undergoing a Norwood procedure. Pre- and post-operative data, neurodevelopment and genetic evaluation information is collected and subjects are followed until 14 months of age. The primary endpoint is death or cardiac transplantation at 12 months of age. An extension of this study has been approved to follow subjects through 6 years post-randomization, with data collected annually between ages 2 and 6 years, as well as before and after the Fontan surgery. Contact: Ismee Williams, MD, MS
• Trial of ACE Inhibition in Infants with Single Ventricle -- a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of administering ACE-I to infants with single ventricle physiology. Data is collected to determine the effect of ACE inhibition on ventricular function and remodeling and patients are followed until 14 months of age. The primary endpoint is weight-for-age Z-score at 14 months of age. Contact: Karen Altmann, MD
• Ventricular Volume Variability Study -- an observational study of children with dilated cardiomyopathy to compare longitudinal data concerning indices of ventricular function and intra- and inter-observer variability. The primary endpoint is inter-study variability of echocardiographic variables; variance at a single point in time and variance of change over time. Contact: Karen Altmann, MD
• Fontan Study -- a cross-sectional study to determine the interrelationships between health status and measures of cardiac performance in children with congenital heart disease who have undergone a Fontan procedure as surgical palliation for functional single ventricle. The primary aim of this study is to determine the relationship between a) laboratory measures of exercise capacity and systemic ventricular function, and b) indices of overall health and functional status in Fontan patients 6 to 18 years of age. Laboratory measures include exercise capacity, MRI assessment, echocardiographic assessment, and biochemical assessment. Contact: Welton Gersony, MD