Congenital Heart DiseaseAPPROACH-IS IINCT04902768
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
An observational study of Congenital Heart Disease, run by KU Leuven at 53 sites in 32 countries.
Trial summary
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 8,415 participants
- Where
- 53 sitesin 32 countries
- Study dates
- 1 Aug 2019to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with congenital heart disease who are in follow-up at an adult congenital heart disease center or included in a national/regional registry. For Part 1 of this study, each participating center will aim to recruit 200 adult patients with CHD aged 18 years or older with simple, moderate, or complex congenital heart disease. For Part 2 of this study, within these samples of 200 patients, centers will aim to recruit about 20 adults aged 40-50y, 20 adults aged 50-60y and 20 adults aged >60 years who are diagnosed with moderate to great disease complexity. Depending on the data collection method, sampling is at random or consecutive. Both a probability and convenience sample can be used.
Who may be able to join
- Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
- Aged 18 years of age or older at the moment of study inclusion
- Diagnosed with congenital heart disease before the age of 10 years
- Follow-up at an ACHD center or included in a national/regional registry
- Physical, cognitive, and language abilities to complete self-report questionnaires
Who cannot join
- Prior heart transplantation
Trial locations and contacts
53 sites in 32 countries.
53 sites in 32 countries
United States10 sites
Taussig Heart Center of Johns Hopkins Hospital
Baltimore, Maryland, 21287
Boston Children's / Brigham and Women's
Boston, Massachusetts, 02115
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Southwestern Medical Center
Dallas, Texas, 75390
University of Florida Health
Gainesville, Florida, 32611
Mount Sinai Heart
New York, New York, 10029
Philadelphia Penn Medicine
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
University of California
San Francisco, California, 92093-0021
Lucile Packard Children's Hospital and Stanford Health Care
Stanford, California, 94304
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg
Skånes Universitetssjukhus
Lund
Karolinska Universitetssjukhuset
Stockholm
Umea University Hospital
Umeå
Uppsala University Hospital
Uppsala
France3 sites
Hôpital cardiologique Haut-Leveque
Bordeaux
Montpellier University Hospital
Montpellier
Hôpital Européen Georges Pompidou
Paris
Switzerland3 sites
University Hospital Bern
Bern
Hôpitaux Universitaires de Genève
Geneva
Centre Hospitalier universitaire vaudois
Lausanne
Argentina2 sites
Hospital San Juan De Dios De La Plata
Buenos Aires
Hospital de Niños
Córdoba
Belgium2 sites
Ghent University Hospital
Ghent
University Hospitals Leuven
Leuven
Canada2 sites
Mazankowski Alberta Heart Institute
Edmonton
Montreal Heart Institute, Université de Montréal
Montreal
United Kingdom2 sites
Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust
London
Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto
Ethiopia1 site
College of Health sciences, Addis Ababa University
Addis Ababa
Malaysia1 site
Paediatric & Congenital Heart Centre, IJN (National Heart Institute)
Kuala Lumpur
Portugal1 site
Reference Center of Congenital Heart Disease , University Hospital Center of São João
Porto
Turkey (Türkiye)1 site
Ege University Health Application and Research Center, Cardiology Department
Bornova
About this study
Official title: APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.
Read the detailed description
The research aims of this study are:
- To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").
- To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").
- Conditions
- Congenital Heart Disease
- Being tested
- This is an observational study, there is no intervention
- Keywords
- Congenital Heart Disease, Quality of life, Patient reported outcomes, Patient reported experience measures, Geriatric phenotype
- 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.
This is an observational study, there is no interventionOther
This is an observational study, there is no intervention. Hence, this is not applicable.
| Study group | Role | What they receive |
|---|---|---|
| Adults with congenital heart disease | Not described Receives: Other: This is an observational study, there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported health status
This outcome is measured using the shortened version of the RAND-36. Composite physical (PCS) and mental health (MCS) scores are computed. Scores range from 0 (lowest health level) to 100 (highest health level).
Measured: Baseline
Patient-reported health status
This outcome is measured using the Linear Analogue Scale Health Status (LAS HS). Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline
Patient-reported depressive symptoms
This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.
Measured: Baseline
Patient-reported anxiety symptoms
This outcome is measured using the General Anxiety Disorder 7. Scores range from 0 to 21. Scores of 5, 10, and 15 are taken as cut-off points for mild, moderate and severe anxiety.
Measured: Baseline
Patient-reported quality of life
This outcome is measured using the Linear Analog Scale on Quality of Life (LAS QOL). Scores range from 0 (worst imaginable quality of life) to 100 (best imaginable quality of life).
Measured: Baseline
Patients' perception of providers' autonomy support
This outcome is measured using the modified Health Care Climate Questionnaire (mHCCQ). Each of the 6 items is scored from 1 to 7. Scores are calculated by averaging the individual item scores. Higher average score represents a higher level of perceived autonomy support.
Measured: Baseline
Cognitive functioning
This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction.
Measured: Baseline
Frailty phenotype
This outcome is classified using the Fried method (i.e., non-frail (no positive criterion), pre-frail (1 or 2 criteria positive), or frail (when ≥3 criteria are positive).
Measured: Baseline
Secondary outcomes (12)
Patient-reported stigma
This outcome is measured using the Chronic Illness Stigma Scale (CISS). Scores range from 8 to 40. Higher scores indicating higher levels of perceived stigma.
Measured: Baseline
Patient-reported illness identity
This outcome is measured using the Illness Identity Questionnaire (IIQ). The questionnaire consists of a five-item rejection scale, seven-item enrichment scale, five-item acceptance scale and eight-item engulfment scale. A mean score is calculated per subscale. Higher scores indicate more rejection, enrichment, acceptance or engulfment.
Measured: Baseline
Patient-reported empowerment
This outcome is measured using the Gothenburg Empowerment Scale (GES generic v1.1). Scores range from 15 to 75. Higher score reflects a higher level of empowerment.
Measured: Baseline
Patient-reported healthcare utilization
This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.
Measured: Baseline
Patient-reported functional status
This outcome is classified according to the New York Heart Association (NYHA).
Measured: Baseline
Patient-reported social support
This outcomes is measured using the Multidimensional Scale on Perceived Social Support Scale (MSPSS). Scores range from 12 to 84. Higher score indicates greater social support perceived by an individual.
Measured: Baseline
Patient-reported parental involvement
This outcome is measured using an adapted version of the subscale on parents of the Multidimensional Scale on Perceived Social Support. Scores range from 5 to 35. Higher score indicates greater parental support in childhood and adolescence.
Measured: Baseline
Advance care planning
This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'Have you personally written down information about the care you would want in case you become seriously ill in the future?'.
Measured: Baseline
Patient-reported social media to connect with peers
This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'How would you describe your experiences connecting with other people with CHD through social media?'.
Measured: Baseline
Presence and burden of comorbidities
This outcome is measured using the Charlson Comorbidity Index.
Measured: Baseline
Patient-reported socio-demographic variables (eg. age, educational level)
Self-reported
Measured: Baseline
Medical variables by chart review (eg. diagnosis, cardiac surgeries)
This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Aug 2019
- Primary completion31 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Moons, KU Leuven
- Investigators
- Philip Moons, PhD, RN, Principal investigator, Professor in Healthcare Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902768
- Sponsor's protocol ID
- S62537
- Acronym
- APPROACH-IS II
- Status last verified
- May 2024
- First submitted
- 20 May 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.
Publications
Van Bulck L, Goossens E, Kovacs AH, Luyckx K, Ladak LA, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Pavao RB, Araujo JJ, Sasikumar N, Gabriel H, Goshu DY, Lu CW, Enomoto J, Areias ME, Kosmidis D, Coats L, Valente AM, Moon JR, Ladouceur M, Thomet C, Jackson JL, Sandberg C, Callus E, Kim YY, Lykkeberg B, Alday L, Bredy C, Saidi A, Reyes FB, Menahem S, de Hosson M, Mandelenakis Z, Christersson C, Zaidi A, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Cedars A, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Moons P; APPROACH-IS II consortium, International Society for Adults Congenital Heart Disease (ISACHD). Advance Care Planning in Adults With Congenital Heart Diseases: Current Practices, Preferences, and Needs of 8,281 Adults From 32 Countries. Can J Cardiol. 2026 Jun;42(6):1338-1348. doi: 10.1016/j.cjca.2025.12.039. Epub 2026 Jan 8.
PubMed 41519299Ansari Ramandi MM, Van Bulck L, Ceelen DCH, Voors AA, Goossens E, Kovacs AH, Luyckx K, Van De Bruaene A, Gabriel H, Lykkeberg B, Thomet C, de Hosson M, Ladouceur M, Saidi A, Kosmidis D, Areias ME, Miranda J, Sandberg C, Mandalenakis Z, Coats L, Amedro P, Khairy P, Valente AM, Johansson B, Kaneva A, Andresen B, Christersson C, Baraona Reyes F, Hlebowicz J, Enomoto J, Kim YY, Menahem S, Yang HL, Moon JR, Bredy C, Schmidt A, Callus E, Araujo JJ, Constantine A, Zaidi A, Bouchardy J, Jameson SM, Kutty S, McGrath LB, Leong MC, Ortiz L, Demir Korkmaz F, Caruana M, Leye M, Moons P, van Melle JP; APPROACH-IS II Consortium; International Society for Adults With Congenital Heart Disease. Quality of Life in Adults With Transposition of the Great Arteries With a Systemic Right or Left Ventricle. Can J Cardiol. 2025 Dec;41(12):2544-2553. doi: 10.1016/j.cjca.2025.09.010. Epub 2025 Sep 15.
PubMed 40962221Moons P, Kovacs AH, Goossens E, Luyckx K, Ladak L, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Manso PH, Araujo JJ, Sasikumar N, Gabriel H, Yadeta D, Wang JK, Enomoto J, Areias ME, Kosmidis D, Coats L, Valente AM, Moon JR, Ladouceur M, Thomet C, Jackson JL, Sandberg C, Callus E, Kim YY, Lykkeberg B, Alday L, Bredy C, Saidi A, Baraona Reyes F, Menahem S, de Hosson M, Hlebowicz J, Christersson C, Zaidi AN, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Kutty S, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Van Bulck L; APPROACH-IS II consortium, on behalf of the International Society for Adults Congenital Heart Disease (ISACHD). Perceived health, psychological distress and quality of life in 8415 adults with congenital heart disease from 32 countries. Heart. 2025 Aug 12;111(17):818-827. doi: 10.1136/heartjnl-2024-325296.
PubMed 40579213Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.
PubMed 34927192
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
- ClinicalTrials.gov ID
- NCT04902768
- Acronym / sponsor ID
- APPROACH-IS II / S62537
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Quality of life, Patient reported outcomes, Patient reported experience measures, Geriatric phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,415 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 May 2021 (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.
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.
Detailed description
The research aims of this study are:
- To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").
- To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with congenital heart disease | – | Other: This is an observational study, there is no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with congenital heart disease who are in follow-up at an adult congenital heart disease center or included in a national/regional registry. For Part 1 of this study, each participating center will aim to recruit 200 adult patients with CHD aged 18 years or older with simple, moderate, or complex congenital heart disease. For Part 2 of this study, within these samples of 200 patients, centers will aim to recruit about 20 adults aged 40-50y, 20 adults aged 50-60y and 20 adults aged >60 years who are diagnosed with moderate to great disease complexity. Depending on the data collection method, sampling is at random or consecutive. Both a probability and convenience sample can be used.
Key inclusion criteria (5 listed)
- Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
- Aged 18 years of age or older at the moment of study inclusion
- Diagnosed with congenital heart disease before the age of 10 years
- Follow-up at an ACHD center or included in a national/regional registry
- Physical, cognitive, and language abilities to complete self-report questionnaires
Key exclusion criteria (1 listed)
- Prior heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study, there is no interventionThis is an observational study, there is no intervention. Hence, this is not applicable. | Other | Adults with congenital heart disease |
Primary outcome
Patient-reported health status
Time frame: Baseline
This outcome is measured using the shortened version of the RAND-36. Composite physical (PCS) and mental health (MCS) scores are computed. Scores range from 0 (lowest health level) to 100 (highest health level).
Patient-reported health status
Time frame: Baseline
This outcome is measured using the Linear Analogue Scale Health Status (LAS HS). Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Patient-reported depressive symptoms
Time frame: Baseline
This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.
Patient-reported anxiety symptoms
Time frame: Baseline
This outcome is measured using the General Anxiety Disorder 7. Scores range from 0 to 21. Scores of 5, 10, and 15 are taken as cut-off points for mild, moderate and severe anxiety.
Patient-reported quality of life
Time frame: Baseline
This outcome is measured using the Linear Analog Scale on Quality of Life (LAS QOL). Scores range from 0 (worst imaginable quality of life) to 100 (best imaginable quality of life).
Patients' perception of providers' autonomy support
Time frame: Baseline
This outcome is measured using the modified Health Care Climate Questionnaire (mHCCQ). Each of the 6 items is scored from 1 to 7. Scores are calculated by averaging the individual item scores. Higher average score represents a higher level of perceived autonomy support.
Cognitive functioning
Time frame: Baseline
This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction.
Frailty phenotype
Time frame: Baseline
This outcome is classified using the Fried method (i.e., non-frail (no positive criterion), pre-frail (1 or 2 criteria positive), or frail (when ≥3 criteria are positive).
12 secondary outcomes
Patient-reported stigma
Time frame: Baseline
Patient-reported illness identity
Time frame: Baseline
Patient-reported empowerment
Time frame: Baseline
Patient-reported healthcare utilization
Time frame: Baseline
Patient-reported functional status
Time frame: Baseline
Patient-reported social support
Time frame: Baseline
Patient-reported parental involvement
Time frame: Baseline
Advance care planning
Time frame: Baseline
Patient-reported social media to connect with peers
Time frame: Baseline
Presence and burden of comorbidities
Time frame: Baseline
Patient-reported socio-demographic variables (eg. age, educational level)
Time frame: Baseline
Medical variables by chart review (eg. diagnosis, cardiac surgeries)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 41519299Van Bulck L, Goossens E, Kovacs AH, Luyckx K, Ladak LA, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Pavao RB, Araujo JJ, Sasikumar N, Gabriel H, Goshu DY, Lu CW, Enomoto J, Areias ME, Kosmidis D, Coats L, Valente AM, Moon JR, Ladouceur M, Thomet C, Jackson JL, Sandberg C, Callus E, Kim YY, Lykkeberg B, Alday L, Bredy C, Saidi A, Reyes FB, Menahem S, de Hosson M, Mandelenakis Z, Christersson C, Zaidi A, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Cedars A, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Moons P; APPROACH-IS II consortium, International Society for Adults Congenital Heart Disease (ISACHD). Advance Care Planning in Adults With Congenital Heart Diseases: Current Practices, Preferences, and Needs of 8,281 Adults From 32 Countries. Can J Cardiol. 2026 Jun;42(6):1338-1348. doi: 10.1016/j.cjca.2025.12.039. Epub 2026 Jan 8.
- Derived from this study: PubMed 40962221Ansari Ramandi MM, Van Bulck L, Ceelen DCH, Voors AA, Goossens E, Kovacs AH, Luyckx K, Van De Bruaene A, Gabriel H, Lykkeberg B, Thomet C, de Hosson M, Ladouceur M, Saidi A, Kosmidis D, Areias ME, Miranda J, Sandberg C, Mandalenakis Z, Coats L, Amedro P, Khairy P, Valente AM, Johansson B, Kaneva A, Andresen B, Christersson C, Baraona Reyes F, Hlebowicz J, Enomoto J, Kim YY, Menahem S, Yang HL, Moon JR, Bredy C, Schmidt A, Callus E, Araujo JJ, Constantine A, Zaidi A, Bouchardy J, Jameson SM, Kutty S, McGrath LB, Leong MC, Ortiz L, Demir Korkmaz F, Caruana M, Leye M, Moons P, van Melle JP; APPROACH-IS II Consortium; International Society for Adults With Congenital Heart Disease. Quality of Life in Adults With Transposition of the Great Arteries With a Systemic Right or Left Ventricle. Can J Cardiol. 2025 Dec;41(12):2544-2553. doi: 10.1016/j.cjca.2025.09.010. Epub 2025 Sep 15.
- Derived from this study: PubMed 40579213Moons P, Kovacs AH, Goossens E, Luyckx K, Ladak L, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Manso PH, Araujo JJ, Sasikumar N, Gabriel H, Yadeta D, Wang JK, Enomoto J, Areias ME, Kosmidis D, Coats L, Valente AM, Moon JR, Ladouceur M, Thomet C, Jackson JL, Sandberg C, Callus E, Kim YY, Lykkeberg B, Alday L, Bredy C, Saidi A, Baraona Reyes F, Menahem S, de Hosson M, Hlebowicz J, Christersson C, Zaidi AN, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Kutty S, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Van Bulck L; APPROACH-IS II consortium, on behalf of the International Society for Adults Congenital Heart Disease (ISACHD). Perceived health, psychological distress and quality of life in 8415 adults with congenital heart disease from 32 countries. Heart. 2025 Aug 12;111(17):818-827. doi: 10.1136/heartjnl-2024-325296.
- Derived from this study: PubMed 34927192Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.
- Individual participant dataSharing planned: No. Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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, PhD, RN principal investigator
Professor in Healthcare Sciences
53 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by KU Leuven at 53 sites in 32 countries.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Sweden, France, Switzerland, Argentina and 27 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported health status (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902768, which also lists 4 linked publications.
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 16 May 2024.