Who is sponsoring NCT04902768?

NCT04902768 is sponsored by KU Leuven.

What drugs are being tested in NCT04902768?

Interventions in NCT04902768: This is an observational study, there is no intervention.

What condition does NCT04902768 study?

NCT04902768 studies Congenital Heart Disease.

Is NCT04902768 still recruiting?

NCT04902768 is currently completed. Last updated 16 May 2024.

Last reviewed 2024-05-16 · How we verify

NCT04902768: APPROACH-IS II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

Completed Last updated 16 May 2024

What this trial tests

trial testing This is an observational study, there is no intervention in Congenital Heart Disease in 8,415 participants. Completed in 31 December 2022.

Timeline

1 August 2019

Primary endpoint
31 August 2022

31 December 2022

Quick facts

Lead sponsor	KU Leuven
Status	Completed
Study type	OBSERVATIONAL
Enrollment	8,415
Start date	1 August 2019
Primary completion	31 August 2022
Estimated completion	31 December 2022
Sites	53 locations across Italy, Colombia, Japan, Malaysia, Taiwan, South Korea, Denmark, Netherlands

Drugs / interventions tested

This is an observational study, there is no intervention

Conditions studied

Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

KU Leuven — full company profile →

Who can join

18 and older, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Moons P, Goossens E, Luyckx K, Kovacs AH, et al · · 2022 · cited 11× · PMID 34927192 · DOI 10.1093/eurjcn/zvab120
Perceived health, psychological distress and quality of life in 8415 adults with congenital heart disease from 32 countries.
Moons P, Kovacs AH, Goossens E, Luyckx K, et al · · 2025 · cited 5× · PMID 40579213 · DOI 10.1136/heartjnl-2024-325296
Quality of Life in Adults With Transposition of the Great Arteries With a Systemic Right or Left Ventricle.
Ansari Ramandi MM, Van Bulck L, Ceelen DCH, Voors AA, et al · · 2025 · cited 1× · PMID 40962221 · DOI 10.1016/j.cjca.2025.09.010
Gothenburg Empowerment Scale (GES): psychometric properties and measurement invariance in adults with congenital heart disease from Belgium, Norway and South Korea.
Acuña Mora M, Raymaekers K, Van Bulck L, Goossens E, et al · · 2022 · cited 1× · PMID 36266608 · DOI 10.1186/s12955-022-02056-z
Advance Care Planning in Adults With Congenital Heart Diseases: Current Practices, Preferences, and Needs of 8,281 Adults From 32 Countries.
Van Bulck L, Goossens E, Kovacs AH, Luyckx K, et al · · 2026 · PMID 41519299 · DOI 10.1016/j.cjca.2025.12.039
Born to Age: When Adult Congenital Heart Disease Converges With Geroscience
Moons P, Marelli A. · · 2022

Verify or expand the search:

Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
NCT07023367 — Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents · NA · recruiting
NCT06833320 — Propranolol Treatment for Postoperative Chylothorax · Phase 1, PHASE2 · recruiting
NCT06668389 — Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary · Phase 4 · recruiting
NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting

Other KU Leuven trials

Trials by the same sponsor.

NCT07508696 — Cerebellar Research in Ultrasound Stimulation · NA · not yet recruiting
NCT07476716 — Peer-modeled Intervention · NA · not yet recruiting
NCT07534384 — Automated CPET Interpretation: International Validation Study · not yet recruiting
NCT07419555 — Belgian Lung Function Study · recruiting
NCT07295600 — Postprandial Effect of Isocaloric Challenge Meals Enriched With Indigenous Fruits and Vegetables on Glucose Metabolism i · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04902768 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by KU Leuven
Last refreshed: 16 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04902768.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing