Clinical trial NCT04335448: Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
Official title: Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transposition of Great Vessels
Keywords: transposition of the great arteries
arterial switch operation
coronary artery anomaly
outcome
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 540
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥16 years) with transposition of great arteries or a Taussig-Bing anomaly who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled. Exclusion criteria are incapability of giving informed consent and previous heart transplant.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults (≥16 years)
* with transposition of great arteries or a Taussig-Bing anomaly
* who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled.

Exclusion Criteria:

* Incapability of giving informed consent and previous heart transplant.

Primary outcomes:
measure: Incidence of all-cause mortality
timeFrame: during a follow up of up to 20 years
measure: Incidence of cardiac-related mortality
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of re-intervention
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of neo-aortic dissection
timeFrame: during a follow up of up to 20 years
measure: Incidence of myocardial infarction
timeFrame: during a follow up of up to 20 years
measure: Incidence of arrhythmias
timeFrame: during a follow up of up to 20 years
measure: Incidence of new onset / worsening heart failure
timeFrame: during a follow up of up to 20 years
measure: Incidence of stroke
timeFrame: during a follow up of up to 20 years
measure: Incidence of infective endocarditis
timeFrame: during a follow up of up to 20 years
measure: Incidence of pulmonary hypertension
timeFrame: during a follow up of up to 20 years
Secondary outcomes:
measure: Rate of right ventricular outflow tract stenosis
timeFrame: during a follow up of up to 20 years
measure: Rate of the different patterns of the coronary anatomy
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of neo-aortic root dilatation
timeFrame: during a follow up of up to 20 years
measure: Incidence of progression of neo-aortic root dilatation
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of neo-aortic regurgitation
timeFrame: during a follow up of up to 20 years
measure: Incidence of progression of neo-aortic regurgitation
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of left ventricular systolic dysfunction
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of left ventricular diastolic dysfunction
timeFrame: during a follow up of up to 20 years
measure: Incidence of worsening left ventricular function
timeFrame: during a follow up of up to 20 years
measure: Incidence/rate of Right ventricular dysfunction
timeFrame: during a follow up of up to 20 years
measure: Incidence of worsening right ventricular function
timeFrame: during a follow up of up to 20 years
measure: Rate of poor functional capacity
timeFrame: during a follow up of up to 20 years
measure: Incidence of pregnancy
timeFrame: during a follow up of up to 20 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Paris
country: France
facility: CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe Valencia
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Inselspital Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Matthias Greutmann, MD
role: PRINCIPAL_INVESTIGATOR
References: