Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
- 试验地点
- 11
- 主要终点
- Incidence/rate of neo-aortic dissection
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Incapability of giving informed consent and previous heart transplant.
结局指标
主要结局
Incidence/rate of neo-aortic dissection
时间窗: during a follow up of up to 20 years
Aortic dissection with entry within the neo-aortic root.
Incidence of myocardial infarction
时间窗: during a follow up of up to 20 years
Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.
Incidence of new onset / worsening heart failure
时间窗: during a follow up of up to 20 years
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.
Incidence of arrhythmias
时间窗: during a follow up of up to 20 years
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.
Incidence of all-cause mortality
时间窗: during a follow up of up to 20 years
Determination of cause of death
Incidence/rate of re-intervention
时间窗: during a follow up of up to 20 years
Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.
Incidence of cardiac-related mortality
时间窗: during a follow up of up to 20 years
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.
Incidence of stroke
时间窗: during a follow up of up to 20 years
Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.
Incidence of infective endocarditis
时间窗: during a follow up of up to 20 years
Defined according to the modified Duke's criteria, according to the current ESC guidelines.
Incidence of pulmonary hypertension
时间窗: during a follow up of up to 20 years
Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.
次要结局
- Incidence/rate of Right ventricular dysfunction(during a follow up of up to 20 years)
- Incidence/rate of neo-aortic root dilatation(during a follow up of up to 20 years)
- Incidence/rate of neo-aortic regurgitation(during a follow up of up to 20 years)
- Incidence of progression of neo-aortic regurgitation(during a follow up of up to 20 years)
- Incidence/rate of left ventricular systolic dysfunction(during a follow up of up to 20 years)
- Incidence of worsening right ventricular function(during a follow up of up to 20 years)
- Incidence of pregnancy(during a follow up of up to 20 years)
- Incidence/rate of left ventricular diastolic dysfunction(during a follow up of up to 20 years)
- Rate of poor functional capacity(during a follow up of up to 20 years)
- Rate of right ventricular outflow tract stenosis(during a follow up of up to 20 years)
- Rate of the different patterns of the coronary anatomy(during a follow up of up to 20 years)
- Incidence of progression of neo-aortic root dilatation(during a follow up of up to 20 years)
- Incidence of worsening left ventricular function(during a follow up of up to 20 years)
研究者
Matthias Greutmann
PD. Dr. med.
University of Zurich