Trial Outcomes & Findings for Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type (NCT NCT02455531)

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

237 participants

Primary outcome timeframe

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

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	mBTTS Blalock Taussig Thomas shunt at Norwood	RVPAS right-ventricular-to-pulmonary-artery shunt at Norwood
Overall Study STARTED	109	128
Overall Study COMPLETED	109	128
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mBTTS n=109 Participants Blalock Taussig Thomas shunt at Norwood	RVPAS n=128 Participants right-ventricular-to-pulmonary-artery shunt at Norwood	Total n=237 Participants Total of all reporting groups
Age, Categorical <=18 years	109 Participants n=5 Participants	128 Participants n=20 Participants	237 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	46 Participants n=20 Participants	93 Participants n=40 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	82 Participants n=20 Participants	144 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	27 Participants n=20 Participants	41 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=5 Participants	100 Participants n=20 Participants	195 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized White	95 Participants n=5 Participants	106 Participants n=20 Participants	201 Participants n=40 Participants
Race/Ethnicity, Customized Non-White	13 Participants n=5 Participants	21 Participants n=20 Participants	34 Participants n=40 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants

PRIMARY outcome

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

Population: participants who underwent cardiac MRI

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

Outcome measures

Outcome measures
Measure	mBTTS n=75 Participants Blalock Taussig Thomas shunt at Norwood	RVPAS n=90 Participants right-ventricular-to-pulmonary-artery shunt at Norwood
RVEF at 10-12 Years on MRI	52 percentage of blood pumped Standard Deviation 7.4	51 percentage of blood pumped Standard Deviation 9.6

SECONDARY outcome

Timeframe: 11 years ± 1 year to 16 years

The incidence of death or cardiac transplantation between those randomized to receive a RVPAS vs. a MBTS at the time of the Norwood operation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 years ± 1 year to 16 years

Exercise capacity: Maximal Oxygen Consumption (VO2max), maximal work rate, and anaerobic threshold

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 years ± 1 year to 16 years

The incidence of arrhythmias between those randomized to a RVPAS vs. a MBTS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 years ± 1 year

Achievement, as measured by the Wechsler Individual Achievement Tests (WIAT) (Math and Reading); Intelligence, as measured by the Wechsler Intelligence Scale for Children (WISC); Other domains of neurodevelopmental function including assessment of language, executive function, visual spatial skills, motor function, memory, social skills, behavior, health-related quality of life (HRQoL) and adaptive function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 years ± 1 year to 16 years

Develop risk stratification models for 1) cardiac outcomes, 2) transplant-free survival, and 3) neurodevelopmental outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 years ± 1 year to 16 years

Collect specimens from subjects and their parents to further develop the biologic specimen repository.

Outcome measures

Outcome data not reported

Adverse Events

mBTTS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

RVPAS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Felicia Trachtenberg

Carelon Research

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place