An observational study in Heart Defects, Congenital, sponsored by KU Leuven. Status unknown at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by KU Leuven · Observational
Many childhood-onset diseases used to be lethal. Improved life expectancy yield that most patients can survive into adulthood, to date. However, survivors of childhood-onset diseases often develop morbidities that suggest accelerated aging. Indeed, age-related conditions are observed sooner and more frequently in people with childhood-onset diseases. Congenital heart disease (CHD) is a typical example of a childhood-onset disease and is the most common birth defect, comprising a spectrum of mild, moderate and complex heart defects. Recent studies showed that age-related morbidities occur more often and at an earlier age in these patients. The overall goal of this project is to quantify and understand disparities in chronological and biological age over the lifespan in CHD patients.
Three main research objectives are proposed:
Objective 1: The investigators will determine the biological age in patients with CHD across the lifespan, using established and novel biomarkers for aging, and assess the disparity with chronological age.
Objective 2: The investigators will identify clinical, behavioral, psychological and social predictors of aging in patients with CHD.
Objective 3: The investigators will investigate the difference in biological-chronological age disparity between patients with CHD and healthy counterparts.
Three studies will be performed to investigate these objectives:
Study 1: Newborns with CHD
- The aim is to (i) compare telomere length in newborns with or without CHD; and (ii) to assess pregnancy-related/clinical and mother-related (behavioral, psychological, social) predictors of telomere length in newborns with CHD.
Study 2: (Young) adults with CHD
- This study aims to (i) compare telomere length in age strata of (young) adults with or without CHD; (ii) to assess clinical, behavioral, psychological, and social predictors of telomere length in patients with CHD; and (iii) to explore the relationship with functional outcomes, such as frailty and cognition.
Study 3: Epigenetic clock in adults with CHD
- This study focusses on (i) assessing the biological age by measuring DNA methylation in mild, moderate and complex heart defects, and (ii) determining if the disparity between biological and chronological age is a function of anatomical complexity and functional status of the patients and (iii) comparing the epigenetic clock of adults with and without CHD.
1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →KU Leuven is the lead sponsor of 371 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newborn with CHD and mother
Inclusion:
Exclusion:
Adults with CHD - study 2
Inclusion:
Exclusion:
Adults with CHD - study 3
Inclusion:
Exclusion
Inclusion:
Exclusion:
Consecutive newborns with CHD (n=100), who are diagnosed and born in the University Hospitals of Leuven and Ghent, are eligible for inclusion. Mothers (n=100) will be asked for participation in the study before delivery and written informed consent will be obtained. Umbilical cord blood of the ENVIRONAGE study (Hasselt University) will be used as a control group.
An age-stratified random sample of (young) adults with CHD, followed-up at the University Hospital of Leuven and the Ghent University Hospital will be included. Age strata for this study are: 18-24y; 25-34y; 35-44y; 45-54y; 55+. In total 500 patients will be included, 100 in each age stratum.
At the University Hospital of Leuven and Ghent University Hospital, patients with selected complex (Fontan operation; Systemic right ventricle), moderate (Tetralogy of Fallot; Coarctation of the aorta), and mild heart defects (isolated atrial septal defect; isolated ventricular septal defect) are eligible. For each type of heart defect 20 patients between the age of 30-50 years are enrolled. The overall sample will comprise 120 patients, who will be part of study 2 as well.
Data on healthy controls (n=500) will be retrieved from blood donors at the blood donation service of the Belgian Red Cross-Flanders. The healthy controls will be matched to the included adult patients (in study 2 and 3) based on sex and age.
Telomere length
Telomere length will be measured on umbilical cord blood from newborns and on peripheral blood from adults with and without CHD.
Time frame: Baseline
Clinical, behavioral, psychological and social predictors of telomere length
This will be studied by using the life history calendar in adults. In newborns, a pregnancy history calendar and correlation with the maternal telomere length will be used.
Time frame: Baseline
Fall history as a functional outcome of aging in adults with CHD
A fall history questionnaire will be used.
Time frame: Baseline
Frailty as a functional outcome of aging in adults with CHD
The Fried method is used for assessment of frailty and consists of five parts: self-report questions about unintentional weight loss, exhaustion and physical activity, an assessment of weakness performed using a handgrip dynamometer, and a walk test. A patient is considered non-frail, pre-frail and frail if, respectively, 0, 1-2 or 3/more components are present.
Time frame: Baseline
Cognitive impairment as a functional outcome of aging in adults with CHD
The Montréal Cognitive Assessment Screener (MoCA) is used for assessment of cognitive function. The maximum score is 30 points, a score of 26 or higher is considered normal. A lower score indicates a worse cognitive function.
Time frame: Baseline
Epigenetic clock in adults with and without CHD
This will be examined based on DNA methylation.
Time frame: Baseline
hsCRP in adults with CHD
Time frame: Baseline
Retina scan in adults with CHD
This will only be performed on patients included in Leuven
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.