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Clinical Trials/NCT05667870
NCT05667870
Recruiting
Not Applicable

A Lifespan Perspective on Accelerated Aging in Congenital Heart Disease

KU Leuven2 sites in 1 country1,200 target enrollmentFebruary 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Defects, Congenital
Sponsor
KU Leuven
Enrollment
1200
Locations
2
Primary Endpoint
Telomere length
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2023
End Date
June 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Philip Moons

Prof. dr.

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Telomere length

Time Frame: Baseline

Telomere length will be measured on umbilical cord blood from newborns and on peripheral blood from adults with and without CHD.

Secondary Outcomes

  • Fall history as a functional outcome of aging in adults with CHD(Baseline)
  • Cognitive impairment as a functional outcome of aging in adults with CHD(Baseline)
  • Epigenetic clock in adults with and without CHD(Baseline)
  • Retina scan in adults with CHD(Baseline)
  • Clinical, behavioral, psychological and social predictors of telomere length(Baseline)
  • hsCRP in adults with CHD(Baseline)
  • Frailty as a functional outcome of aging in adults with CHD(Baseline)

Study Sites (2)

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