NCT04335448: EPOCH-ASO

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation

Active, enrolled Last updated 8 November 2022

What this trial tests

trial testing No intervention is planed in Transposition of Great Vessels in 540 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2019

Primary endpoint
30 September 2039

30 September 2039

Quick facts

Lead sponsor	University of Zurich
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	540
Start date	1 October 2019
Primary completion	30 September 2039
Estimated completion	30 September 2039
Sites	11 locations across France, Netherlands, Austria, Switzerland, Spain

Drugs / interventions tested

• No intervention is planed

Conditions studied

• Transposition of Great Vessels — all drugs for Transposition of Great Vessels →

Sponsor

University of Zurich

Who can join

16 and older, any sex, with Transposition of Great Vessels. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO.

Methods: The comprehensive long-term follow up of adults with ASO is a project within the European collaboration for prospective outcome research in congenital heart disease (EPOCH). It is designed as a prospective, international multicenter cohort study. Consecutive patients (aged 16 years or more) with prior ASO will be included at 11 European tertiary care centers. Participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. Main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. Secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. The impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed.

Aim: The prospective, international, multicenter EPOCH-ASO study will provide a better understanding of adverse outcomes and their predictors in adults after ASO. The results of the EPOCH-ASO study may help to optimize future care of this novel patient cohort in adult cardiology.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Aortic coarctation and long-term morbidity after arterial switch operation: a multicentre international cohort study.
   Ruperti-Repilado FJ, Ladrón R, Lopez-Ayala P, Gabra B, et al · · 2026 · PMID 40701798 · DOI 10.1136/heartjnl-2024-325634