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

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

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

Study Overview

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

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:

• Study Type: Observational
• Enrollment (Actual): 901

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Institut Saint Pierre / Chu Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COHORTE PRECOHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of recoarctation after coarctation surgery	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.	Up to 14 years post-surgery (2011-2025).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global survival in patient operated of coarctation	Proportion of patient that died (what ever the cause) after their surgery and during the follow up.	2011-2025 (14 years
Proportion of systemic hypertension at last follow up in patient operated of aortic coarctation	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.	2011-2015 (14 years)
Predictors of recoarctation	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.	Up to 14 years post-surgery

Collaborators and Investigators

• Sponsor: Institut Saint Pierre
• Investigators: Study Director: Oscar WERNER, Dr WERNER, non afilié; Principal Investigator: charlotte duseigneur, institu saint pierre

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Risk Factors; mortality; Survival Analysis; Cohort Studies Retrospective Studies
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hypertension; Death; Postoperative Complications; Aortic Coarctation
• Other Study ID Numbers: 2025-09-338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data including:

Demographic characteristics (age, sex, birth weight, gestational age) Surgical details (type of repair, associated procedures) Follow-up outcomes (hypertension, recoarctation, cardiac reinterventions, mortality) Imaging results (echocardiography, CT scan if performed)

• IPD Sharing Time Frame: IPD will be available after publication of the main results and for a period of 5 years.
• IPD Sharing Access Criteria: No individual participant data will be shared
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No