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

NCT07499609 | Completed

• 1 other identifier: 2025-09-338
• Study Type: observational
• Target: 901
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Cohort Studies Retrospective Studies; Risk Factors; mortality; Survival Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• global survival in patient operated of coarctation

  2011-2025 (14 years

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

  2011-2015 (14 years)

• Predictors of recoarctation

  Up to 14 years post-surgery

Study Arms (1)

COHORTE PRECOHA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Institut Saint Pierre: lead

Study Sites (1)

Institut Saint Pierre / Chu Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Aortic Coarctation; Hypertension; Postoperative Complications; Death

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar WERNER, Dr WERNER

  non afilié

  STUDY DIRECTOR

• charlotte duseigneur

  institu saint pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

FR (1)