Genetic Determinants of Congenital Heart Disease Outcomes

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Brief Title

Genetic Determinants of Congenital Heart Disease Outcomes

Official Title

The GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes

Brief Summary

      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.
    

Detailed Description

      For physicians caring for children with congenital cardiac defects, perhaps the greatest
      challenge is to improve the survival and functional outcomes of patients with severe defects
      requiring surgical repair or palliation in the first month of life. These cardiac defects can
      be associated with 5 year mortality rates of up to 30% with significant disabilities in many
      of the survivors. As with every medical condition, patient outcomes depend on the complex
      interaction of the disease process, the medical and surgical interventions to treat the
      disease, and the inherent capacity of the patient to respond to both the disease and its
      treatment.

      For patients with severe cardiac defects, the greatest risk for morbidity and mortality
      occurs during and shortly after their neonatal surgical repair. During surgery to repair
      severe cardiac defects, the body is cooled and the heart is stopped. In many cases, blood
      flow to the vital organs is interrupted or restricted for a significant period of time while
      the aortic arch is reconstructed. This process places profound stress on the patient's
      capacity to tolerate these insults without sustaining irreversible injury to tissues such as
      the heart, brain, and kidneys. That there is such a wide range of outcomes after this
      surgery, even between patients with similar clinical features, suggests that there are
      important individual differences in patients' abilities to respond to this stress that is
      determined by differences in their genetic traits.

      The importance of the interaction between the controlled trauma of the surgical environment
      and a patient's genetic background in determining patient outcomes has led to the new
      discipline of "peri-operative genomics." In this study, we will examine the contribution of
      gene-environment interactions to perioperative and short-term outcomes in neonates with
      severe congenital cardiac defects.
    


Study Type

Observational


Primary Outcome

Contribution of genetic variation in oxidative stress management to differences in short term outcomes after repair for severe cardiac disease in the neonatal period

Secondary Outcome

 Contribution of genetic variation in oxidative stress management to differences in interstage mortality and pre-Stage II cardiovascular function in patients with single ventricle cardiac disease

Condition

Congenital Heart Disease


Study Arms / Comparison Groups

 d-Transposition of the Great Arteries
Description:  Neonates with d-transposition of the great arteries (dTGA) undergoing the arterial switch operation with cardiopulmonary bypass

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

800

Start Date

March 2011

Completion Date

December 2026

Primary Completion Date

December 2024

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Known trisomy 13, 18, or 21

          -  Any major non-cardiac anomaly that precludes the patient from cardiac surgery
      

Gender

All

Ages

N/A - 30 Days

Accepts Healthy Volunteers

No

Contacts

Nicole S Wilder, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT01656941

Organization ID

GECHO


Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Collaborators

 Royal Children's Hospital

Study Sponsor

Nicole S Wilder, MD, Principal Investigator, University of Michigan


Verification Date

July 2020