This competing renewal application aims to demonstrate that the Prairieland Consortium (PC) has the patient population, faculty and staff expertise, clinical services, research resources, and enrollment and follow-up successes to continue as an outstanding and productive member of the NHLBI?s Pediatric Heart Network. The PC is unique in that it is comprised of two pediatric cardiovascular programs located at Cincinnati Children?s Hospital Medical Center (CCHMC) in Cincinnati, OH, and Riley Hospital for Children (RHC), in Indianapolis, IN. This consortium is led by an established collaboration between Dr. James F. Cnota at the University of Cincinnati College of Medicine, and Dr. R. Mark Payne at Indiana University School of Medicine. Together, the institutions are responsible for more than 1,000 cardiothoracic surgeries, >14,000 patient visits, and >20,000 in-house echocardiograms per year. Unique features of this collaboration include a large and diverse population in the heartland of America for recruitment and enrollment into clinical studies, strong CTSA?s at both institutions supporting the infrastructure, excellent and collaborative clinical research coordinator teams, established and robust bioinformatics infrastructures, and meaningful integration of clinical cardiology, basic science, and surgical services at both sites.
In Aim 1, we will utilize our pediatric and ACHD clinics to recruit and enroll subjects into approved PHN protocols, and support long-term cohort follow-up. We will pursue high enrollment rates, and collect patient data and samples per approved protocols. We will rapidly enter de- identified electronic data and deliver biological samples to PHN repositories to meet Network goals and standards.
In Aim 2, we will develop and implement research protocols for clinical and translational trials. Our 2 centers will continue to hold frequent scheduled videoconferences and in-person meetings to generate new ideas, data, and protocols for submission to the NIH and PHN for consideration. In particular, we will include our strong cardiovascular genetic and basic science colleagues in these discussions to develop new clinical and translational protocols. We will utilize our respective CTSA?s to help develop and pilot preliminary studies that will be used to generate full protocols for submission to the PHN. We will continue actively to participate in PHN meetings and committees, protocol review and development, industry and NIH sponsored trials, and educational missions of the PHN. The long-term goal of our participation in the PHN is to advance the care and understanding of children with congenital and acquired heart disease. The Prairieland Consortium is eager to continue its collaboration with other clinical centers, the data-coordinating center (NERI), the NHLBI staff, and industry partners to complete ongoing studies and initiate innovative new investigations.

Public Health Relevance

This is a collaborative project between two large mid-western institutions to study heart disease in children and young adults. This is the most common birth defect. The goal of this project is to develop new understanding that will lead to improved diagnosis and new therapies to lessen the burden of heart disease in children and young adults.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1HL135678-05
Application #
10078967
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Li, Huiqing
Project Start
2017-01-01
Project End
2023-12-31
Budget Start
2021-01-01
Budget End
2021-12-31
Support Year
5
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
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