Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type

NCT02455531 | Active Not Recruiting Results DMC

• 2 other identifiers: U10HL068270-4bU10HL068270
• Study Type: observational
• Target: 237
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.

Conditions

Heart Defects

Outcome Measures

Primary Outcomes (1)

• RVEF at 10-12 Years on MRI

  RV ejection fraction (RVEF) at 10-12 years, as measured by cardiac magnetic resonance (CMR).

  assessed between 10-12 years of age, an average of 53.2 days from consent

Secondary Outcomes (6)

• Death or Cardiac Transplantation

  11 years ± 1 year to 16 years

• The Exercise Tolerance Between Those Randomized to a RVPAS vs. a MBTS.

  11 years ± 1 year to 16 years

• Atrial and Ventricular Arrhythmias

  11 years ± 1 year to 16 years

• The Neurodevelopmental Outcomes at 11 Years of Age in Those Randomized to a RVPAS vs. a MBTS

  11 years ± 1 year

• Risk Stratification Models

  11 years ± 1 year to 16 years

Study Arms (1)

Transplant-free survivors

Transplant-free survivors of the SVR cohort (All SVR survivors are eligible to be followed for vital status.)

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All SVR study cohort members will be contacted to assess for vital status. Transplant free survivors will be approached to participate in the in-person assessment.

You may qualify if:

• All SVR study cohort members will be contacted to assess for vital status. Transplant free survivors will be approached to participate in the in-person assessment.

You may not qualify if:

• Patients who have undergone cardiac transplantation or biventricular conversion from all outcomes other than vital status.
• Those with pacemakers will be excluded from the CMR, and patients \<130 cm in height will be excluded from the exercise test.

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (1)

• Miller TA, Sharma B, Gongwer R, Trachtenberg FL, Newburger JW, Goldberg CS, Gustafson KE, Gaynor JW, Votava-Smith JK, Lambert LM, Sananes R, Kral MC, Tsang R, Heinrich KP, Cnota J, Shah A, Ilardi D; Pediatric Heart Network Investigators. Neurodevelopmental Outcomes in Early Adolescence: The Pediatric Heart Network's Single Ventricle Reconstruction Trial. Circulation. 2025 Oct 28;152(17):1246-1261. doi: 10.1161/CIRCULATIONAHA.125.074523. Epub 2025 Jul 17.

  PMID: 40671650 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Participants and their parents who have not yet contributed to the SVR Extension biorepository will be offered the opportunity to provide saliva for extraction and storage of DNA. If study participants have consented to participate in the biorepository through the SVR Extension study but not yet contributed a sample, they will be asked to contribute at the time of the SVR III participation. Families who were not previously approached, or who declined participation in the biorepository earlier, may be offered the opportunity to participate at the time of the SVR III participation.

Limitations and Caveats

We cannot exclude enrollment bias or survival bias.

Results Point of Contact

• Title: Dr. Felicia Trachtenberg
• Organization: Carelon Research

Felicia.Trachtenberg@carelon.com

Felicia.Trachtenberg@carelon.c

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 28, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2025
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-03