Clinical Research

World-Class Clinical Research

The Heart Institute at Cincinnati Children’s Hospital Medical Center – a fully integrated cardiac institute for children – is nationally recognized for advancing the fields of pediatric cardiology and cardiac surgery by designing a program that fosters clinical expertise, supports research initiatives and provides educational opportunities for fellows, residents and specialists.

From Bench To Bedside

The Heart Institute merges the diverse activities of clinical care, research, education, operations and outcomes improvement. This approach drives the exchange of information between bench and bedside, and that facilitates each discipline’s ability to respond to the other. The result is world-class pediatric heart care.

Pediatric Heart Network

Cincinnati Children’s Hospital Medical Center is one of only eight core sites within the Pediatric Heart Network (PHN) across the United States and Canada. PHN protocols conducted at Cincinnati Children's include the Marfan trial, the Infant Single Ventricle (ISV) trial, the Single Ventricle Reconstruction (SVR) trial and the Single Ventricle Reconstruction Extension (SVRII) trial. Currently, subjects are being actively recruited for the Marfan trial and the SVRII study.

• Investigators
• Cincinnati Children's Core Site Primary Investigator – D. Woodrow Benson, MD, PhD
• Current Studies
• Marfan trial
  Site Primary Investigator – D. Woodrow Benson, MD, PhD
  Co-investigators Haleh Heydarian, MD; Robert B. Hinton, Jr, MD; Linda H. Cripe, MD
• Single Ventricle Reconstruction Extension trial
  Site Primary Investigator – Catherine Krawczeski, MD
  Co-investigator Karen Uzark, PhD, CPNP

Preventive Cardiology

The section of Preventive Cardiology was formed in the 1990s with the consolidation of clinical and research efforts to solve the problems of hypertension, high cholesterol, and obesity-related cardiovascular complications such as left ventricular hypertrophy and vascular dysfunction. Research personnel include physicians, nurses, registered dieticians, statisticians, research assistants and support staff.

Preventive Cardiology is currently collaborating with members of the Divisions of Cardiology, Endocrinology, Nephrology, Pulmonology, Radiology, Biostatistics and Epidemiology along with researchers at the University of Cincinnati in providing vascular function testing, study design and data analyses.

• Investigators
• Elaine Urbina, MD
• Holly Ippisch, MD, MS
• Phil Khoury
• Current Studies
• Effect of adipocytokines on vascular function
• CV complications of type 2 diabetes or sleep apnea
• CV changes in offspring of mothers with type 1 diabetes
• Effects of early weight gain on future obesity
• Effects of high fat meal and exercise on endothelial function

Cardiac Magnetic Resonance Imaging

The Cardiac MRI (CMR) Program began in 2003 and incorporates both clinical diagnostic testing and clinical research. The research focuses on hypothesis-driven studies utilizing the unique capabilities of CMR in characterizing intricacies of heart function. An example of our current line of research has been in defining the natural history of the cardiac dysfunction associated with Duchenne Muscular Dystrophy. This has involved focusing on regional myocardial function/strain, synchrony, perfusion, viability and energetics.

Other areas currently under investigation include the study of both energetics and contractile reserve in postoperative tetralogy of Fallot patients, and the establishment of normal chamber size and functional data for the pediatric population. The CMR research includes and leverages the participation of investigators from several disciplines.

• Investigators
• Pediatric Cardiology
• William M. Gottliebson, MD, MS
• Kan N. Hor, MD
• D. Woodrow Benson, MD, PhD
• Linda Cripe, MD
• Radiology
• Robert Fleck, MD
• Janaka Wansapura, PhD
• Amy Tipton, BFA
• Eric J. Crotty, MD
• Kathy J. Helton, MD 
• Internal Medicine Cardiology
• Wojciech Mazur, MD (The Christ Hospital / Ohio Heart)
  Biomedical Engineering, University of Cincinnati
• Ashish Das, MS
  Rupak Banerjee, PhD

Quality Of Life Outcomes Research In Children With Heart Disease

As survival in children with chronic health conditions has improved, quality of life has emerged as an important health outcome. Investigators at Cincinnati Children’s are leaders in the field of quality of life measurement in children with heart disease. The quality of life measures developed and utilized here not only include disease-specific measures with greater clinical utility in assessing concerns that are particular to this patient population, but also include both parent-proxy and child self-report measures, so essential to quality of life assessment given the observed lack of significant agreement between proxy- and self-report, ‘cross-informant variance’, demonstrated in multiple pediatric studies.

Read more about Outcomes Research being conducted at the Heart Institute.

• Investigators
• Karen Uzark, PhD, CPNP
• Bradley Marino, MD, MPP, MSCE

Cardiac Intensive Care Unit

Clinical research in the Cardiac Intensive Care Unit (CICU) at Cincinnati Children's Hospital Medical Center is abundant and focuses on improving short- and long-term outcomes for children and adults with critical heart disease.

• Study Team
  
  Faculty from the CICU collaborate with investigators from around North America as part of several multi-center studies. Our study team includes a dedicated group of:
• Research coordinators
• CICU physicians and nurses
• Cardiothoracic surgeons
• Cardiac anesthesiologists
• Statisticians

We also have a strong collaboration with other areas at Cincinnati Children's, such as the Division of Nephrology.

• Current Studies
  
  In addition to the Pediatric Heart Network studies, our current studies are:
• Evaluating the incidence of acute kidney injury after cardiopulmonary bypass
• Studying biomarkers which may diagnose kidney injury very early after bypass
• Following patients long-term to determine the effects of kidney injury on long-term outcome, including quality of life

Other areas currently under investigation include the evaluation of the amino acid citrulline to prevent postoperative pulmonary hypertension and the evaluation of novel non-invasive ways to measure cardiac output in pediatric cardiac patients.

• Investigators
• Pediatric Cardiology
• Catherine Krawczeski, MD
• Angela Lorts, MD
• Bradley Marino, MD
• Cardiothoracic Surgery
• Peter Manning, MD
• Pirooz Eghtesady MD
• Nephrology
• Prasad Devarajan, MD
• Research Coordinators
• Teresa Barnard, RN
• Rachel Griffiths, RN
• Tracey VanVliet, RN

Fetal Heart Program

The Fetal Heart Program at Cincinnati Children's Hospital Medical Center is dedicated to improving the care and outcomes of fetuses with a variety of cardiovascular conditions. Clinical research is central to our mission to improving outcomes. Research focuses on hypothesis-driven clinical and animal research studies, and is aimed at characterization of cardiovascular abnormalities in a variety of pathologic fetal conditions.

• Investigators
• Erik C. Michelfelder, MD, Director
• James F. Cnota, MD
• Allison Divanovic, MD (fellow who will be joining faculty July 1, 2009)
• Current Studies
• Echocardiographic identification of highly restrictive/intact atrial septum in the fetus with hypoplastic left heart syndrome 
• Quantitative evaluation of cardiovascular abnormalities in twin-twin transfusion syndrome 
• The relationship between cardiovascular status and recipient twin outcomes in twin-twin transfusion syndrome 
• Characterization of cardiovascular changes in twin reversed arterial perfusion sequence, fetal lung masses, and vascular fetal tumors 
• Evaluation of cardiovascular function during experimental cardiopulmonary bypass in the sheep fetus 
• Accuracy and reliability of telemedicine-based fetal echocardiography 
• Factors influencing prenatal diagnosis of congenital heart disease
  

Contact the Heart Institute at Cincinnati Children's

For more information or to schedule an appointment, please contact the Heart Institute at Cincinnati Children's Hospital Medical Center.

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