Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease (PRECARDIO)

December 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood

The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. Acute kidney injury is a common complication of cardiac surgery in children. The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known. The only study published to date is that of Dimopoulos et al., who has estimated the prevalence of CKD in young adults with congenital cardiac diseases at 40% and the prevalence of stage 2 CKD at 6% (Dimopoulos, Circulation 2008). The study by Dimopoulos et al. also showed that CKD was a risk factor of death in this population. Objectives. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could be predictive of CKD.

Methodology. The study has been approved by the Ethical Committee of our institution, and is founded by the Departement de la Recherche Clinique et du Developpement, AP-HP, Paris This is a prospective observational cross-sectional study which will enroll patients 10 to 15 years with congenital cardiac diseases, who have undergone surgical repair during childhood. Only patients who have undergone surgery and follow-up at our institution will be enrolled, to insure complete data. The patients will receive complete information about the study by mail that will be send home prior to the appointment for the cardiologic follow-up. After parental and patient consent, a sample of blood and urine will be collected for purpose of the study. CKD will be diagnosed according to the KDIGO criteria in children (Hogg, Pediatrics 2003). In case of CKD, patients will be informed and given an appointment for nephrological support and follow-up at our institution. The prevalence and stage of CKD will be calculated after completion of inclusions. The risk factors of CKD will be identified retrospectively by chart review and regression analysis.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker - Enfants Malades Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 10 to 15 years old with congenital cardiac diseases

Description

Inclusion Criteria:

  • Patient aged 10 to15 years, having undergone surgery for congenital heart disease during childhood, and cardiologic follow-up at Necker-Enfants Malades Hospital
  • Written informed consent by one parent
  • Health insurance

Exclusion Criteria:

  • Documented chronic kidney disease of non cardiac origin
  • Documented kidney or urinary malformation
  • Failure to puncture a peripheral vein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
congenital cardiac diseases
blood sample and urine sample.
Biological: blood and urine samples
A blood sample and urine sample will be collected for purpose of the study. CKD (Chronic kidney injury) will be diagnosed according to the KDIGO criteria in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic kidney disease
Time Frame: at Day 0
The primary measure is the prevalence of chronic kidney disease in teenagers and pre-teenagers with congenital heart disease operated during childhood. For screening purposes, a blood and a urine sample will be collected the day of consultation for the cardiologic follow-up.
at Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative risk factors
Time Frame: at day 0
The secondary aim is the identification of peri-operative risk factors of chronic kidney disease in this population, by retrospective chart-review and regression analysis.
at day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Mirela Bojan, MD, Necker - Enfants Malades Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2013

Primary Completion (Actual)

June 19, 2015

Study Completion (Actual)

June 20, 2015

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimated)

May 3, 2013

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P091125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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