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

Transposition of Great Vessels Clinical Trial

— EPOCH-ASO  

Official title:

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04335448
• Other study ID #: EPOCH
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: September 30, 2039

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: September 30, 2039
• Est. primary completion date: September 30, 2039
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transposition of Great Vessels

Intervention

Other:
• No intervention is planed
No intervention is planed

Locations

Country	Name	City	State
Austria	University Hospital Vienna	Vienna
France	CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou	Paris
Netherlands	Amsterdam University Medical Center	Amsterdam
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario y Politécnico La Fe Valencia	Valencia
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Inselspital Bern	Bern
Switzerland	University Hospital Geneva	Geneva
Switzerland	University Hospital Lausanne	Lausanne
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Austria,  France,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all-cause mortality	Determination of cause of death	during a follow up of up to 20 years
Primary	Incidence of cardiac-related mortality	Sudden cardiac death (death that ensues unexpected within one hour of onset of symptoms), death related to acute myocardial infarction, death that is primarily caused by heart failure or death within 30 days or during the hospital admission after a cardiac intervention.	during a follow up of up to 20 years
Primary	Incidence/rate of re-intervention	Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.	during a follow up of up to 20 years
Primary	Incidence/rate of neo-aortic dissection	Aortic dissection with entry within the neo-aortic root.	during a follow up of up to 20 years
Primary	Incidence of myocardial infarction	Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.	during a follow up of up to 20 years
Primary	Incidence of arrhythmias	Atrial arrhythmias with a duration of >30 seconds, or requiring anti-arrhythmic medication or ablation procedures and / or sustained ventricular tachycardia (heart rate >100/min) for at least 30 seconds or requiring electrical cardioversion / defibrillation.	during a follow up of up to 20 years
Primary	Incidence of new onset / worsening heart failure	Hospital admission for heart failure or initiation of heart failure medication for symptoms of heart failure (excludes initiation of medication for asymptomatic deterioration of ventricular function), according to the current guidelines of the European Society of Cardiology.	during a follow up of up to 20 years
Primary	Incidence of stroke	Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.	during a follow up of up to 20 years
Primary	Incidence of infective endocarditis	Defined according to the modified Duke's criteria, according to the current ESC guidelines.	during a follow up of up to 20 years
Primary	Incidence of pulmonary hypertension	Defined as an increase in mean pulmonary arterial pressure (PAPm) =20 mmHg at rest as assessed by right heart catheterization.	during a follow up of up to 20 years
Secondary	Rate of right ventricular outflow tract stenosis	At least 1 of the following criteria: Branch pulmonary artery minimal diameter: maximal diameter at least 1:2 on CT or MRI; Echocardiographic systolic peak gradient across branch pulmonary arteries > 16mmHg (peak velocity > 2.0m/s); Estimated right ventricular systolic pressure > 40mmHg (determined by RV/RA-pressure gradient and estimated central venous pressure, see echocardiography protocol for details)	during a follow up of up to 20 years
Secondary	Rate of the different patterns of the coronary anatomy	To study the impact of coronary artery anatomy and type of coronary reimplantation on cardiovascular morbidity, ventricular function and functional capacity with a specific focus on presence of coronary artery obstruction, acute proximal angulation and inter-arterial or intramural course.	during a follow up of up to 20 years
Secondary	Incidence/rate of neo-aortic root dilatation	Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.	during a follow up of up to 20 years
Secondary	Incidence of progression of neo-aortic root dilatation	Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.	during a follow up of up to 20 years
Secondary	Incidence/rate of neo-aortic regurgitation	Assessment by echocardiography: - Mild, moderate, severe (50); Assessment by CMR; - Regurgitation fraction and volume by flow measurements in proximal aortic root.	during a follow up of up to 20 years
Secondary	Incidence of progression of neo-aortic regurgitation	Increase > 1 grade (echocardiography) Increase of regurgitant fraction >10% on CMR.	during a follow up of up to 20 years
Secondary	Incidence/rate of left ventricular systolic dysfunction	Echocardiography: - Left ventricular ejection fraction (LVEF) biplane Simpson <52% for men and <54% for women (33); CMR: - LVEF < 52%	during a follow up of up to 20 years
Secondary	Incidence/rate of left ventricular diastolic dysfunction	Echocardiography: - Defined according to the current recommendations for the evaluation of left ventricular diastolic function by the America society of echocardiography and the European association of cardiovascular Imaging.	during a follow up of up to 20 years
Secondary	Incidence of worsening left ventricular function	Decrease of LVEF >5%	during a follow up of up to 20 years
Secondary	Incidence/rate of Right ventricular dysfunction	Echocardiography: - At least 2 of the following; FAC <30%; TAPSE <18mm; TAPSE S' <10cm/s; CMR: - RVEF < 50%	during a follow up of up to 20 years
Secondary	Incidence of worsening right ventricular function	Echocardiography (not valid in case of worsening tricuspid regurgitation) - At least 2 of the following: Decrease in Fac > 10%; Decrease in TAPSE >5mm; Decrease in TAPSE S' >3cm/s; CMR: - Decrease in RVEF >5%	during a follow up of up to 20 years
Secondary	Rate of poor functional capacity	As determined by cardiopulmonary exercise testing by measuring Lung Function (flow volume loops), oxygen consumption during exercise (VO2 max), anaerobic threshold, heart performance during exercise (O2-Heart rate)	during a follow up of up to 20 years
Secondary	Incidence of pregnancy	To study the impact of pregnancy on mortality and cardiovascular morbidity.	during a follow up of up to 20 years