Accelerated Aging in Newborns and Adults With Congenital Heart Disease

Recruiting

• Conditions: Heart Defects, Congenital

• Registration Number: NCT05667870
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-28
• Study First Posted: 2022-12-29
• Study Start: 2023-02-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hsCRP in adults with CHD	Baseline
Fall history as a functional outcome of aging in adults with CHD	Baseline	A fall history questionnaire will be used.
Cognitive impairment as a functional outcome of aging in adults with CHD	Baseline	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.
Epigenetic clock in adults with and without CHD	Baseline	This will be examined based on DNA methylation.
Retina scan in adults with CHD	Baseline	This will only be performed on patients included in Leuven
Clinical, behavioral, psychological and social predictors of telomere length	Baseline	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.
Frailty as a functional outcome of aging in adults with CHD	Baseline	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.

Trial Locations

Locations (2)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium