NCT07499609

Prevalence and Risk Factors for Hypertension and Recoarctation in Patients Operated for Aortic Coarctation

PRECOHA ; Prevalence and Risk Factors for Hypertension and Recoarctation in Patients Operated for Aortic Coarctation After Early Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 901 (actual)
• Sponsor: Institut Saint Pierre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Multicenter Retrospective Study Over a 14-Year Period From 2010 to 2024

Detailed description

Inclusion of all neonates and infants who underwent surgical repair of aortic coarctation within the first year of life in one of the five participating surgical centers. From antenatal data to postoperative complications. Very large table. Event-free survival (events: death, recoarctation, cardiac reinterventions, hypertension) Description of patients who developed recoarctation Univariate and multivariate analysis of determinants of recoarctation (+/- death): patients with recoarctation versus others (excluding those who died without recoarctation). Main Predictive Factors and Primary Criteria to Be Tested: Antenatal diagnosis of coarctation: yes/no Prematurity: yes/no and subgroups (24-32 weeks vs. 32-37 weeks vs. term) Intrauterine growth restriction (IUGR): yes/no; IUGR vs. small for gestational age vs. normal weight Birth weight \< 2500 g vs. \> 2500 g Prostaglandin infusion: yes/no Duration of prostaglandin infusion (days) Ventricular septal defect (VSD): yes/no Bicuspid aortic valve: yes/no Hemodynamic failure: yes/no Aortic valve size: \< -2 Z-score Horizontal aorta \< 3.6 mm vs. \> 3.6 mm CT scan performed: yes/no Age at surgery: \< or \> 1 month Surgical technique: patch vs. simple/extended Crafoord repair Associated procedure: yes/no Length of ICU stay (days) Postoperative cardiovascular complication: yes/no Postoperative isthmic peak velocity: \< or \> 2 m/sec Data Collection Excel database including 934 patients from 5 centers. 127 columns from A (Anonymization number) to DX (Date of hypertension diagnosis). Primary endpoint: Prevalence and morbidity/mortality. Data divided into 13 sections: Sociodemographic data: Follow-up center, responsible physician Antenatal data: Follow-up and echocardiography results Delivery: Neonatal clinical presentation: Diagnostic echocardiography: Preoperative CT scan if performed: First intervention: Post-intervention echocardiography Second intervention if performed: Recoarctation with surgical intervention: Recoarctation with catheter intervention Last follow-up data: Weight, height, blood pressure, date of last visit, last news Date of death Exercise test results if available:

Conditions

• Aortic Coarctation
• Retrospective Studies
• Cohort Studies
• Hypertension
• Risk Factors
• Infant, Newborn
• Postoperative Complications
• Reoperation
• Mortality
• Death
• Cardiac Surgery

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: France