NCT03070197 is a clinical trial of Exposure of interest: Brain MRI in Heart Disease Congenital, sponsored by Children's Hospital Medical Center, Cincinnati.

Who is sponsoring NCT03070197?

NCT03070197 is sponsored by Children's Hospital Medical Center, Cincinnati.

What drugs are being tested in NCT03070197?

Interventions in NCT03070197: Exposure of interest: Brain MRI, Exposure of interest: neurodevelopmental assessments.

What condition does NCT03070197 study?

NCT03070197 studies Heart Disease Congenital.

Is NCT03070197 still recruiting?

NCT03070197 is currently completed. Last updated 13 August 2020.

Last reviewed 2020-08-13 · How we verify

NCT03070197

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes)

Completed Last updated 13 August 2020

What this trial tests

trial testing Exposure of interest: Brain MRI in Heart Disease Congenital in 196 participants. Completed in 29 June 2020.

Timeline

18 September 2017

Primary endpoint
29 June 2020

29 June 2020

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Status	Completed
Study type	OBSERVATIONAL
Enrollment	196
Start date	18 September 2017
Primary completion	29 June 2020
Estimated completion	29 June 2020
Sites	8 locations across United States

Drugs / interventions tested

Exposure of interest: Brain MRI
Exposure of interest: neurodevelopmental assessments

Conditions studied

Heart Disease Congenital — all drugs for Heart Disease Congenital →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

8 and older, any sex, with Heart Disease Congenital. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Approximately 400 Congenital heart disease patients will participate in the research study which will include one or more research visits for neurodevelopmental testing, brain MRI, and collection of medical history including previously collected genetic sequencing results. The investigators will explore the association between genetic variants, neurodevelopmental deficits, and brain MRI endophenotype. Analyses will compare groups with and without deleterious de novo mutations.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Association of genetic and sulcal traits with executive function in congenital heart disease.
Maleyeff L, Newburger JW, Wypij D, Thomas NH, et al · · 2024 · cited 5× · PMID 38009418 · DOI 10.1002/acn3.51950
Noncoding variants and sulcal patterns in congenital heart disease: Machine learning to predict functional impact.
Mondragon-Estrada E, Newburger JW, DePalma SR, Brueckner M, et al · · 2025 · cited 2× · PMID 39877905 · DOI 10.1016/j.isci.2024.111707
Machine learning to infer neurocognitive testing scores among adolescents and young adults with congenital heart disease.
Hussain MA, He S, Adams HR, Anagnoustou E, et al · · 2026 · PMID 41651962 · DOI 10.1038/s43856-026-01417-9

Verify or expand the search:

Other recruiting trials for Heart Disease Congenital

Currently open trials in the same condition.

NCT06690151 — Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal · recruiting

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
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NCT07265141 — An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics · NA · not yet recruiting
NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03070197 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
Last refreshed: 13 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03070197.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing