Aortic CoarctationPRECOHANCT07499609
Prevalence and Risk Factors for Hypertension and Recoarctation in Patients Operated for Aortic Coarctation
An observational study of Aortic Coarctation and Retrospective Studies, run by Institut Saint Pierre at 1 site in France.
Trial summary
Multicenter Retrospective Study Over a 14-Year Period From 2010 to 2024 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Coarctation, Retrospective Studies, Cohort Studies
- How many people
- 901 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Keywords
- Cohort Studies Retrospective Studies, Risk Factors, mortality, Survival Analysis
- Medical subject headings
- Aortic Coarctation, Hypertension, Postoperative Complications, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COHORTE PRECOHA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 years post-surgery (2011-2025).
Secondary outcomes (3)
global survival in patient operated of coarctation
Proportion of patient that died (what ever the cause) after their surgery and during the follow up.
Measured: 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.
Measured: 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.
Measured: Up to 14 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar WERNER, Dr WERNER, Study director, non afiliécharlotte duseigneur, Principal investigator, institu saint pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499609
- Sponsor's protocol ID
- 2025-09-338
- Acronym
- PRECOHA
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECOHA ; Prevalence and Risk Factors for Hypertension and Recoarctation in Patients Operated for Aortic Coarctation After Early Surgery
- ClinicalTrials.gov ID
- NCT07499609
- Acronym / sponsor ID
- PRECOHA / 2025-09-338
- Conditions
- Aortic Coarctation, Retrospective Studies, Cohort Studies, Hypertension, Risk Factors, Infant, Newborn
- Keywords
- Cohort Studies Retrospective Studies, Risk Factors, mortality, Survival Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Institut Saint PierreUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COHORTE PRECOHA | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
global survival in patient operated of coarctation
Time frame: 2011-2025 (14 years
Proportion of systemic hypertension at last follow up in patient operated of aortic coarctation
Time frame: 2011-2015 (14 years)
Predictors of recoarctation
Time frame: Up to 14 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar WERNER, Dr WERNER study director
non afilié
charlotte duseigneur principal investigator
institu saint pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coarctation and Retrospective Studies, run by Institut Saint Pierre at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of recoarctation after coarctation surgery (time frame: Up to 14 years post-surgery (2011-2025).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.