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Completed

NCT Number: NCT07499609

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

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

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Key information

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of recoarctation after coarctation surgery

    Time frame: Up to 14 years post-surgery (2011-2025).

    Prevalence of recoarctation among patients operated for aortic coarctation before one year of age.

    Recoarctation is defined by a cardiac catheterisme that showed a reduction of the lumen avec aortic isthmus of 50% and/or a peak-to-peak gradient > 20mmHg at the level of the recoarctation.

    Survival analysis without recoarctation

    Percentage of patients and Kaplan-Meier survival curves.

Secondary outcomes

  1. global survival in patient operated of coarctation

    Time frame: 2011-2025 (14 years

    Proportion of patient that died (what ever the cause) after their surgery and during the follow up.

  2. Proportion of systemic hypertension at last follow up in patient operated of aortic coarctation

    Time frame: 2011-2015 (14 years)

    Regarding the systemic hypertension outcome, patients were classified as hypertensive at their last out-patient visit if they presented with diastolic and/or systolic blood pressure above the 95th percentile (according to sexe, age and height) or if they were under antihypertensive drugs To establish the onset date of systemic hypertension, outpatient cardiology visits were retrospectively reviewed from the most recent to the earliest encounter to identify: 1) the first abnormal blood pressure value and/or 2) the introduction of a hypertensive drugs.

  3. Predictors of recoarctation

    Time frame: Up to 14 years post-surgery

    Outcomes associated to recoarctation will be assessed using univariate and multivariate logistic regression models. Variables considered include demographic, anatomical, and surgical characteristics (e.g., prematurity, birth weight, prostaglandin use, surgical technique). Comparisons will be made between patients who developed recoarctation and those who did not, excluding patients who died without recoarctation Analysis of potential predictive factors using univariate and multivariate models.

Sponsors and collaborators

Lead sponsor

Institut Saint Pierre

Other

Registry information

Official study title

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

Acronym: PRECOHA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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