Prognosis in Adult Patients with Congenital Heart Disease: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- major cardiac arrhytmias
研究概览
简要总结
This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled.
The primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization).
The secondary endpoints are: 1) evaluation of the incidence of the singular components of the primary endpoint; 2) evaluation of the prognostic impact of acquired lesions, including valve disease not present at birth; 3) need for surgical/percutaneous interventions during follow up.
Participants will be evaluated in the context of scheduled follow-up visits in our Outpatient ACHD Clinic. No interventions/drug administration will be performed other than those required by standard clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
- •Age ≥ 18 years
排除标准
- •Patients without congenital heart disease confirmed during the first evaluation
- •Impossibility to retrieve information about the first clinical evaluation in our clinic from our electonic datasets
- •Follow up shorter than one-year
- •Refused consent to participate to the study.
结局指标
主要结局
major cardiac arrhytmias
时间窗: 5 years
occurence of ventricular and/or atrial arrhythmias
cardiovascular outcomes
时间窗: 5 years
composite endpoint of death and cardiac hospitalization
次要结局
- changes in echocardiographic parameters over time(12 months)
- heart valve disease (new-onset or progression)(12 months)
研究者
Graziani Francesca
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS