Pulmonary Artery Growth in Tetralogy of Fallot: A Look at Nakata Index Over Time
Official title: Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Run by University Hospital, Strasbourg, France · NCT07864129 · Data updated 2026-11-12
This study tests how pulmonary artery sizes change from birth through surgery in kids with Tetralogy of Fallot to see if the Nakata index can help guide treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | June 18, 2026 |
| Main results expected | April 18, 2027 |
| Study ends | June 18, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07864129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children from birth up to 18 years who underwent treatment for Tetralogy of Fallot or pulmonary atresia with VSD at Strasbourg or Bordeaux University Hospitals between 2010 and 2024, with available pulmonary artery measurements.
✕Probably not a fit
Patients without available imaging data or those with forms of the condition not meeting the study criteria may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter retrospective observational study analyzes serial measurements of pulmonary artery dimensions using the Nakata index at birth, after palliative procedures, and after complete repair in children with Tetralogy of Fallot or pulmonary atresia with VSD. Data are drawn from Strasbourg and Bordeaux University Hospitals between 2010 and 2024. The goal is to understand whether Nakata index trends can better inform surgical planning and improve outcomes. No active interventions are performed; the study relies on existing medical records to identify patterns. Findings could support more personalized timing and sequencing of surgeries in congenital heart disease.
Why it matters
Potential benefit: If successful, the study could help clinicians predict optimal surgical timing and potentially improve long-term heart and lung outcomes for affected children.
How similar studies have gone: Other studies using Nakata index in congenital heart disease have provided useful predictive information, but this specific longitudinal, multicenter retrospective approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged from birth to less than 18 years * Patients operated at Strasbourg or Bordeaux University Hospitals between 01/01/2010 and 31/12/2024 * Patient (or legal guardians) not opposing the reuse of medical data for research purposes Exclusion Criteria: * Patient expressing opposition to participation in the study * Parents/legal guardians or minor opposing data reuse * Specific clinical forms (VDDI) * Absence of subvalvular obstruction and absence of muscular resection
Where it's running
-
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Laurent Bonnemains, MD, PhD
- Email: laurent.bonnemains@chru-strasbourg.fr
- Phone: 33 3 88 12 74 99
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.