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

Institut Saint Pierre

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT07499609

2025-09-338

Details and patient eligibility

About

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

Full 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:

Enrollment: 901 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 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.

Among associated intracardiac lesions, patients with ventricular septal defect (VSD), atrial septal defect (ASD), bicuspid aortic valve, and persistent left superior vena cava are also included.

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Exclusion Criteria: Children with complex congenital heart disease (e.g., transposition of the great arteries, double outlet right ventricle, single ventricle, truncus arteriosus, interrupted aortic arch) are excluded. Patients that underwent angioplasty as first intervention will also be excluded.

Trial design

901 participants in 1 patient group

COHORTE PRECOHA