Genetic Determinants of Congenital Heart Disease Outcomes

Completed

Conditions studied: Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, d-Transposition of the Great Arteries

In brief

The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. The goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.

Key facts

Study ID

NCT01656941

Run by

University of Michigan

People needed

250

Starts

2011-03-01

Expected to finish

2017-03-16

Last updated by the study team

2021-08-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• d-transposition of the great arteries or single ventricle cardiac disease
• Less than or equal to 30 days of age
• Planned arterial switch operation or stage I surgical palliation (Norwood)with aortic arch reconstruction

You may not qualify if…

• Known trisomy 13, 18, or 21
• Any major non-cardiac anomaly that precludes the patient from cardiac surgery

Where it is running

• Emory University — Atlanta, Georgia, United States
• C.S. Mott Children's Hospital, University of Michigan Health System — Ann Arbor, Michigan, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• The Royal Children's Hospial Melbourne — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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