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NCT05667870
Accelerated Aging in Newborns and Adults With Congenital Heart Disease
Conditions: Heart Defects, Congenital
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 1200
Sponsor: KU Leuven
Location: Belgium
Summary
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.
Eligibility Criteria
Newborn with CHD and motherInclusion:Newborns with CHD who are diagnosed and born in UZ Leuven or UZ GentThe mother is able to adequate fill out the questionnairesInformed consent is signedExclusion:The mother does not speak DutchThe 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 stenosisAdults with CHD - study 2Inclusion:≥ 18 years of age at the moment of study inclusionDiagnosed with CHDFollow-up at the UZ Leuven or UZ GentSigned informed consentPhysical, cognitive, and language abilities to complete self-report questionnaires/ assessment testsExclusion:Not speaking DutchVery 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 stenosisThe heart defect falls within a syndrome condition (e.g., Down syndrome, 22q11 deletion)Adults with CHD - study 3Inclusion:Included in study 2≥ 18 years of age at the moment of study inclusionFollow-up at the UZ Leuven or UZ GentSigned informed consentPhysical, cognitive, and language abilities to complete self-report questionnaires/ assessment testsHaving 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.ExclusionNot speaking DutchThe heart defect falls within a syndrome condition (e.g., Downsyndrome, 22q11 deletion)Health volunteersInclusion:Male or female healthy volunteers of the Red CrossAged 18 - 65 years at the moment of inclusionThe healthy volunteers must match with the patients included in study 2 based on age and sexSigned informed consentThe requirements of the Red Cross for blood donation are fulfilledExclusion:Medical history of cardiac, pulmonal, renal or liver disease, chronic anemia, blood clotting disorderNot speaking DutchPregnancyBorn with a heart condition
Source: ClinicalTrials.gov (NCT05667870). StuddyBuddy aggregates publicly available trial information.