Heart Defects, CongenitalAccelerAGENCT05667870
Accelerated Aging in Newborns and Adults With Congenital Heart Disease
An observational study of Heart Defects, Congenital, run by KU Leuven at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- How many people
- 1,200 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 Feb 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Newborns with CHD and mother 2. Adults with CHD - study 2 For each age stratum 100 patients must be included (Gent and Leuven combined), so a total of 500 patients will be included: 18-24 years of age, 25-34 years of age, 35-44 years of age, 45-54 years of age, ≥ 55 years of age 3. Adults with CHD - study 3 These patients must also be included in study 2. The patients must have 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. Furthermore, they need to be between 30-50 years old. 4. Healthy volunteers Health volunteers of the Red Cross.
Who may be able to join
- 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
- ≥ 18 years of age at the moment of study inclusion
- Diagnosed with CHD
- Follow-up at the UZ Leuven or UZ Gent
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- Signed informed consent
- Physical, cognitive, and language abilities to complete self-report questionnaires/ assessment tests
- 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.
- 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
Who cannot join
- 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
- Adults with CHD - study 2
- 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
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- The heart defect falls within a syndrome condition (e.g., Down syndrome, 22q11 deletion)
- Adults with CHD - study 3
- Not speaking Dutch
- The heart defect falls within a syndrome condition (e.g., Downsyndrome, 22q11 deletion)
- Health volunteers
- Medical history of cardiac, pulmonal, renal or liver disease, chronic anemia, blood clotting disorder
- Not speaking Dutch
- Pregnancy
- Born with a heart condition
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital
Ghent
Julie De Backer, PhD, MD, 09/3323344, julie.debacker@ugent.be
Tijs Tournoy, MD
- Not yet recruiting
University Hospital Leuven
Leuven
Philip Moons, PhD, RN, 016/373315, philip.moons@kuleuven.be
Bo Daelman, MSc
About this study
Official title: A Lifespan Perspective on Accelerated Aging in Congenital Heart Disease
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.
Read the 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.
- Conditions
- Heart Defects, Congenital
- Keywords
- Congenital heart disease, Aging
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newborns with CHD and their mothers | 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. | |
| (Young) adults with CHD - study 2 | 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. | |
| (Young) adults with CHD - study 3 | 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. | |
| Healthy controls | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length
Telomere length will be measured on umbilical cord blood from newborns and on peripheral blood from adults with and without CHD.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Baseline
Fall history as a functional outcome of aging in adults with CHD
A fall history questionnaire will be used.
Measured: 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.
Measured: 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.
Measured: Baseline
Epigenetic clock in adults with and without CHD
This will be examined based on DNA methylation.
Measured: Baseline
hsCRP in adults with CHD
Measured: Baseline
Retina scan in adults with CHD
This will only be performed on patients included in Leuven
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start20 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Hasselt University
- Responsible party
- Principal investigator, Philip Moons, KU Leuven
- Investigators
- Philip Moons, Prof. PhD, Principal investigator, Professor in Healthcare Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667870
- Sponsor's protocol ID
- S66590
- Acronym
- AccelerAGE
- Status last verified
- Jun 2023
- First submitted
- 14 Dec 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifespan Perspective on Accelerated Aging in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05667870
- Acronym / sponsor ID
- AccelerAGE / S66590
- Conditions
- Heart Defects, Congenital
- Keywords
- Congenital heart disease, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Hasselt University
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Newborns with CHD and their mothers | – | –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. |
| (Young) adults with CHD - study 2 | – | –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. |
| (Young) adults with CHD - study 3 | – | –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. |
| Healthy controls | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Newborns with CHD and mother 2. Adults with CHD - study 2 For each age stratum 100 patients must be included (Gent and Leuven combined), so a total of 500 patients will be included: 18-24 years of age, 25-34 years of age, 35-44 years of age, 45-54 years of age, ≥ 55 years of age 3. Adults with CHD - study 3 These patients must also be included in study 2. The patients must have 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. Furthermore, they need to be between 30-50 years old. 4. Healthy volunteers Health volunteers of the Red Cross.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (15 listed)
- Adults with CHD - study 2
- Adults with CHD - study 3
- Health volunteers
- Medical history of cardiac, pulmonal, renal or liver disease, chronic anemia, blood clotting disorder
- Not speaking Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Clinical, behavioral, psychological and social predictors of telomere length
Time frame: Baseline
Fall history as a functional outcome of aging in adults with CHD
Time frame: Baseline
Frailty as a functional outcome of aging in adults with CHD
Time frame: Baseline
Cognitive impairment as a functional outcome of aging in adults with CHD
Time frame: Baseline
Epigenetic clock in adults with and without CHD
Time frame: Baseline
hsCRP in adults with CHD
Time frame: Baseline
Retina scan in adults with CHD
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Moons, Prof. PhD principal investigator
Professor in Healthcare Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital, run by KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Moons, PhD, RN (016/373315, philip.moons@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.