RESEARCH AND INNOVATION

We support groundbreaking research and innovation geared toward driving improvements in care and outcomes and developing new therapies for the next generation.

M-CHORD is our unique research core within the Congenital Heart Center supported by dedicated faculty and staff. Our comprehensive expertise spans the spectrum of clinical investigation and accelerates novel and collaborative science.

We are one of nine centers across the country selected to participate in the PHN, funded by the National Institutes of Health. Through this network our patients have access to clinical trials of cutting-edge therapies and interventions. A list of active studies can be found at: www.pediatricheartnetwork.org/studies.

U-M Investigators collaborated with the PHN to lead a variety of efforts in 2022. Examples include:

Comparison of Methods of Pulmonary Blood Flow

Augmentation in Neonates: Shunt Versus Stent (COMPASS) — the first randomized trial to compare a catheter-based intervention vs. surgery in the CHD population. U-M investigators are collaborating with the PHN and two national CNU registries to lead the COMPASS trial, which is studying infants with ductaldependent pulmonary blood flow. The trial started in 2022 with U-M as the first enrollment site.

U-M investigators launched the T-NOX trial in 2021, which compares strategies for oxygen delivery (normoxia vs. hyperoxia) in infants undergoing congenital heart surgery. In 2022, the T-NOX trial team reached the 50% enrollment mark.

U-M cares for one of the largest populations of Fontan patients worldwide, and our investigators lead multiple projects focused on improving long-term Fontan outcomes. Studies include:

• Fontan Circulatory Failure Study

We are the lead site for the largest study to date examining the role of Fontan-associated complications, frailty, and resilience on heart failure outcomes. This study now includes 20 active sites across the country.

• Fontan Wellness Program

We lead Data Core activities for Cardiac Networks United (CNU), which integrates nine large networks spanning more than two-thirds of the nation’s congenital heart programs. The Data Core houses one of the largest collections of CHD data worldwide and accelerates collaborative research and quality improvement activities.

Our investigators lead this large multi-center trial which is a supplemental study to the PHN Fontan Udenafil Exercise Longitudinal (FUEL) Open-Label Extension (OLE) trial. The FALD trial recently completed enrollment and will shed new light on Fontanassociated liver disease.

U-M leads biorepository efforts for the PHN, supporting investigations in the precision medicine realm to understand unique traits influencing CHD outcomes

Our unique U-M clinical research program is aimed at improving overall wellness and long-term outcomes in adolescents and adults with Fontan-palliated heart disease. This program combines virtual resiliency skills training (WE BEAT) with virtual exercise training (HEART Club). Early results from our first three cohorts are very encouraging. To date, the WE BEAT resiliency skills training program has been rated at nearly 9 out of 10 in a satisfaction survey by participants and the HEART Club is changing the ways in which our patients safely exercise at home.

We are the lead site for this PHN-funded study looking at the associations between social determinants of health and mental health in patients with Fontan circulation. This study uses self-report and parent-reported measures to assess psychological functioning and adverse social determinants of health in 130 patients. To increase diversity of the study population, two other leading children’s hospitals were included as additional enrolling sites.

U-M is participating in a study to test whether patientspecific stem cells injected into the hearts of children with hypoplastic left heart syndrome can improve heart strength and other outcomes in this population.

Through multiple projects, our team is investigating mechanisms to improve opportunities and advancement for women and minorities in the field. Two national analyses conducted in 2021 have paved the way to understanding the current state in pediatric cardiology and congenital heart surgery, setting the stage for future investigation.