Pediatric Heart Network
The Division 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.
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. Ismee Williams, MD, MS
- ACE Inhibition in Infants with Single Ventricle. Karen Altmann, MD
- Ventricular Volume Variability Study: An observational study of children with dilated cardiomyopathy. Karen Altmann, MD
The Pulmonary Hypertension Center is currently participating in several multicenter national and international clinical trials of novel therapeutics for the treatment of pulmonary arterial hypertension, as well as genetic and pharmacogenetic studies to further understand mechanisms of disease and differences in clinical phenotypes of patients with pulmonary hypertension.
- Ambrisentan pharmacokinetics in pulmonary hypertension and Eisenmenger Syndrome: To assess the safety and efficacy of the endothelin receptor antagonist ambrisentan. Erika Berman Rosenzweig, MD
- Multicenter clinical trials of oral Cicletanine, oral Remodulin, inhaled Treprostinil, inhaled Iloprost, Seraphin Oil and Imatinib: Investigations to explore the safety and efficacy of new therapeutics for the treatment of neonates, infants, children and adults with pulmonary hypertension. Erika Berman Rosenzweig, MD
- Dhreams Study: A multicenter NIH funded study to develop a better understanding of the molecular genetic basis of congenital diaphragmatic hernia (CDH), which is a cause of pulmonary hypertension. Erika Berman Rosenzweig, MD or Wendy Chung, MD, PhD
Non-invasive Imaging and Electrophysiology
The Non-invasive Imaging Laboratory and the section of electrophysiology are involved in multiple protocols focused on the evaluation of ventricular function in children with heart disease by echocardiography, cardiac magnetic resonance imaging, and the study of arrhythmias. It is also integrally involved in other protocols in that require the precise diagnosis and non-invasive evaluation of cardiovascular anomalies in fetuses and children as well as the medical and ablative techniques for irregular heart electrical function. Wyman W. Lai, MD, MPH and Leonardo Liberman, MD
The fetal cardiology section within the Division of Pediatric Cardiology performs fetal Doppler ultrasound and electrocardiographic monitoring. The goal of the studies is to assess the association of prenatally diagnosed congenital heart disease and Hydrops Fetalis, other extra-cardiac anomalies and fetal blood flow as a predictor of neurodevelopment. In addition the group is studying fetal EKG’s as a diagnostic tool to diagnosis and treat arrhythmias. Ismee Williams MD, MS, Julie Glickstein MD, Stephanie Levasseur, MD
The cardiac catheterization laboratory participates in multiple multicenter trials that involve the development and assessment of new transcatheter devices and transcatheter treatment modalities for patients with congenital/structural heart disease. The laboratory is also involved in validation studies focused on innovative, non-invasive ways to assess hemodynamic data (such as cardiac output and mixed venous saturation) at the bedside or at ambulatory outpatient evaluations. Finally, the lab is involved in multicenter, safety and efficacy trials for specific devices as well as follow-up registries and outcome assessment protocols.
- Congenital Cardiac Catheterization Outcomes Project: A multicenter study to assess adverse events and outcomes of diagnostic and interventional cardiac catheterizations in congenital heart disease. Julie A. Vincent, MD
- Detection of Atherosclerosis with Intravascular Ultrasound (IVUS) and Cardiac Computed Tomography Angiography (CCTA) in Familial Hypercholesterolemia: A pilot study to evaluate the presence and severity of coronary and aortic atherosclerosis in patients with homozygous and heterozygous familial hypercholesteremia.
Julie A. Vincent, MD
- Multicenter clinical trials to assess aortic and pulmonary valvuloplasty. Alejandro Torres MD and Julie Vincent, MD
- Multicenter clinical trials to assess the use of stents in coarctation of the aorta and aortic injury. Julie Vincent, MD
- AGA ADO II Clinical Study: A multicenter trial to further assess safety and efficacy of the new Amplatzer Duct Occluder II device (AGA Medical) for transcatheter closure of the patent ductus arteriosus and closure of atrial septal defects under an FDA IDE protocol. Julie A. Vincent, MD
Heart Failure and Cardiac Transplantation
The section of heart failure and transplantation was the first program in the United States to perform heart transplants in children. Today it remains one of the largest and most prestigious programs providing cutting edge patient care and research. The team participates in multicenter clinical trials and registries that study and evaluate heart failure, cardiomyopathy and transplantation.
- Genetic Contributions to Graft and Patient Outcomes: An NIH-funded multicenter study that addresses how HLA incompatibility, mediators of inflammation, and immunosuppressive drug efficacy influence cardiac transplantation outcome in pediatric patients. Linda J. Addonizio, MD
- Alloantibodies in Cardiac Transplantation: An NIH-funded multicenter study (CTOTC) with the primary objective to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity cross-match and to compare them with outcomes in non-sensitized participants. Linda J. Addonizio, MD
- Interagency Registry of Mechanically Assisted Circulatory Support: A national clinical follow-up study that will assess factors such as death, explant, rehospitalization, and three adverse events neurological dysfunction, infection, and device malformation. Jonathen Chen, MD
- Outcomes of Surgical Treatment for Hypertrophic Obstructive Cardiomyopathy: A retrospective chart review of pediatric patients with hypertrophic obstructive cardiomyopathy who underwent left ventricular septal myomectomy and/or mitral valve replacement. Linda J. Addonizio, MD
- Impact of Immunosuppressive Therapy and EBV Status on Risk of Post Transplant Lymphoproliferative Disease: A retrospective chart review of pediatric patients who underwent heart transplantation to examine the impact of type of immunosuppression therapy and donor and recipient EBV status in relation to risk of subsequent PTLD. Linda J. Addonizio, MD
- Risk Factors in Pediatric Cardiac Transplantation: A retrospective review of all patients who underwent heart transplantation at the Children's Hospital of New York Presbyterian to determine risk factors for mortality and graft loss. Linda J. Addonizio, MD
Pediatric Cardiopulmonary Laboratory
Measured Oxygen Consumption during the Six Minute Walk Test (6MWT) in Patients with Pulmonary Arterial Hypertension (PAH): A study designed to demonstrate a relationship between 6MWT distance, Borg Dyspnea Score, per cent peak VO2 and peak VO2 in repeated measurement in the same subject over time. Robert Garofano, PhD
General Pediatric Cardiology
Pediatric Systemic Hypertension: A prospective multi-center NIH funded study designed to evaluate a non-invasive behavioral modification therapy in the treatment of hypertension in children. Contact. Thomas J. Starc, MD, MPH
Columbia University is one of the five Pediatric Cardiac Genomics Consortium centers funded by the NHLBI to elucidate the underlying genetic basis for cardiac disease in children. Working with investigators at Harvard University, Yale University, Mount Sinai, and the Children's Hospital of Philadelphia, we are studying children with structural heart disease and their parents using the most sophisticated modern genetics methods including copy number variation, genetic association studies, and sequencing of candidate genes and whole exomes. These studies seek to identify what causes congenital heart disease, to assist families in determining prognosis, and to assess risk of having another child with congenital heart disease. Wendy Chung, MD, PhD
In the Developmental Biology research program within the Division of Cardiology, we aim to further our understanding of the genetic determinants of cardiac morphogenesis through the study of model organisms. The transparent zebrafish embryo is ideal, as it allows for microscopic observation of the developing heart throughout embryogenesis. Furthermore, Zebrafish do not require a functional cardiovascular system for survival until well after cardiac chamber formation is complete. The large volume of embryos that are readily obtained in the laboratory provides us with a powerful tool for genetic analysis. Currently, our research is focused on the study of NKX2.5, a cardiac-specific homeodomain transcription factor that is known to cause different types of heart defects. As additional causative genes are identified in human genetics, we will take advantage of the benefits of the zebrafish model as a means to understand the mechanisms underlying congenital heart disease. Kimara L. Targoff, MD