NHLBI selects U-M Congenital Heart Center for clinical research

Pediatric Heart Network sites to focus on improving outcomes for babies born with congenital heart disease

The University of Michigan Congenital Heart Center has been selected as a new Pediatric Heart Network core site for clinical research.  Created and funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, the Pediatric Heart Network is a cooperative network of pediatric cardiovascular clinical research centers that conducts studies in children with congenital or acquired heart disease.  

Researchers will receive $2.25 million over five years to help develop and lead clinical trials designed to improve outcomes for children with congenital heart disease. Richard G. Ohye, M.D., associate professor at the U-M Medical School Department of Surgery and co-director of the Michigan Congenital Heart Center and Caren S. Goldberg, M.D., clinical associate professor in the Department of Pediatrics and Communicable Diseases, will serve as primary investigators. They have worked with the Pediatric Heart Network on two prior studies focused on the best surgical options for children with hypoplastic left heart syndrome.

"This grant will enable the Congenital Heart Center to continue to track the progress of children born with hypoplastic left heart syndrome and help us determine the best treatment for them, which we will then share with other heart centers to provide the best possible care for these children," Ohye says. "This award recognizes the Congenital Heart Center's strong commitment to become international leaders in developing therapies to improve child health."

The Michigan Congenital Heart Center will function as one of nine core sites across the nation and Canada that will be co-recipients of $19.6 million core clinical center funding allocated by the Pediatric Heart Network. The U-M program was selected for its history of successful pediatric cardiac research and its leadership in ongoing Pediatric Heart Network endeavors including the Single Ventricle Reconstruction trial and Single Ventricle Reconstruction Extension Study.

The Pediatric Heart Network is a group of hospitals in the United States and Canada that conducts research studies in children with congenital or acquired heart disease. Congenital heart defects occur in approximately 40,000 infants in the U.S. each year and are a major cause of infant death. Acquired heart disease can cause death and long-term disability.

In the past 25 years, fewer than 40 randomized clinical trials have been done in patients with congenital or acquired heart disease.  There are several reasons for this.  Many hospitals or single doctors do not see enough children with any one type of heart disease in order to perform certain studies and have meaningful results.  Parents have been unable to enter their children into studies because they are not aware of them, they don't live near a research site or may have reservations about enrolling their child.

"By building a community between highly-esteemed research institutions in Michigan, across the country and Canada, we are able to work together to ensure better outcomes for children with cardiac diseases," Goldberg says.