Understanding accelerated aging in newborns and adults with congenital heart disease

A Lifespan Perspective on Accelerated Aging in Congenital Heart Disease

This study is trying to understand how aging works differently in newborns and adults with congenital heart disease compared to healthy people by looking at markers that show biological age.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: KU Leuven (other)
• Locations: 2 sites (Ghent and 1 other locations)
• Trial ID: NCT05667870 on ClinicalTrials.gov

What this trial studies

This observational study aims to quantify and understand the disparities in chronological and biological aging in patients with congenital heart disease (CHD). It will assess biological age using established and novel biomarkers, identify predictors of aging, and compare biological age disparities between CHD patients and healthy individuals. The study will involve newborns and adults with CHD, focusing on telomere length and epigenetic markers to explore aging processes. The research will be conducted at UZ Leuven and UZ Gent, utilizing questionnaires and assessments to gather data.

Who should consider this trial

Good fit: Ideal candidates include newborns diagnosed with congenital heart disease and adults aged 18 and older with a history of CHD.

Not a fit: Patients with very mild heart defects or those who do not speak Dutch may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of age-related health issues in patients with congenital heart disease.

How similar studies have performed: While studies on aging in CHD patients are emerging, this specific approach focusing on biological versus chronological age is relatively novel.

Eligibility criteria

1. Newborn with CHD and mother

   Inclusion:
   * Newborns with CHD who are diagnosed and born in UZ Leuven or UZ Gent
   * The mother is able to adequate fill out the questionnaires
   * Informed consent is signed

   Exclusion:
   * The mother does not speak Dutch
   * The heart defect falls within a syndrome condition (e.g., Down syndrome, 22q11 deletion)
   * Very mild heart defects such as a patent foramen ovale, an open ductus of Botalli (no intervention needed), spontaneous closure of ASD/VSD, an isolated mild peripheral pulmonary stenosis
2. Adults with CHD - study 2

   Inclusion:
   * ≥ 18 years of age at the moment of study inclusion
   * Diagnosed with CHD
   * Follow-up at the UZ Leuven or UZ Gent
   * Signed informed consent
   * Physical, cognitive, and language abilities to complete self-report questionnaires/ assessment tests

   Exclusion:
   * Not speaking Dutch
   * Very mild heart defects such as a patent foramen ovale, an open ductus of Botalli (no intervention needed), spontaneous closure of ASD/VSD, an isolated mild peripheral pulmonary stenosis
   * The heart defect falls within a syndrome condition (e.g., Down syndrome, 22q11 deletion)
3. Adults with CHD - study 3

   Inclusion:
   * Included in study 2
   * Between 30-50 years of age at the moment of study inclusion
   * Follow-up at the UZ Leuven or UZ Gent
   * Signed informed consent
   * Physical, cognitive, and language abilities to complete self-report questionnaires/ assessment tests
   * Having one of the following CHD conditions: isolated arterial septal defect, isolated ventricular septal defect, tetralogy of Fallot, coarctation of the aorta, Fontan operation or systemic right ventricle.

   Exclusion
   * Not speaking Dutch
   * The heart defect falls within a syndrome condition (e.g., Downsyndrome, 22q11 deletion)
4. Health volunteers

Inclusion:

* Male or female healthy volunteers of the Red Cross
* Aged 18 - 65 years at the moment of inclusion
* The healthy volunteers must match with the patients included in study 2 based on age and sex
* Signed informed consent
* The requirements of the Red Cross for blood donation are fulfilled

Exclusion:

* Medical history of cardiac, pulmonal, renal or liver disease, chronic anemia, blood clotting disorder
* Not speaking Dutch
* Pregnancy
* Born with a heart condition

Where this trial is running

Ghent and 1 other locations

• Ghent University Hospital — Ghent, Belgium (RECRUITING)
• University Hospital Leuven — Leuven, Belgium (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Philip Moons, Prof. PhD — Professor in Healthcare Sciences
• Study coordinator: Philip Moons, PhD, RN

Conditions: Heart Defects, Congenital, Congenital heart disease, Aging