Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by Cardiac Magnetic Resonance Imaging and Exercise Test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- NYHA Class
研究概览
简要总结
Title:
Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach
Background:
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential.
Aim:
Assess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR.
Identify predictors of arrhythmia using strain and clinical parameters.
Methods:
Design: Prospective observational study over one year.
Population: Adults (≥18 years) with repaired TOF undergoing follow-up CMR.
Assessments:
Clinical evaluation (NYHA class)
Echocardiography (RV size, function, valve status)
Laboratory tests (BNP, NT-proBNP)
Exercise testing (METs, VO₂ max)
ECG & 24-hour Holter monitoring (QRS duration, arrhythmias)
CMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV)
Outcomes:
Primary: Functional assessment of repaired TOF patients.
Secondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation).
Statistical Analysis:
Comparison between arrhythmic and non-arrhythmic groups.
Logistic regression for predictors of arrhythmia.
ROC analysis to determine optimal strain cut-off values.
Ethical Considerations:
Ethics committee approval and informed consent.
Data confidentiality maintained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
NYHA Class
时间窗: 1 year
New York Heart Association (NYHA) classification 1 to 4
cardiac magnetic resonance (CMR)
时间窗: 1 years
myocardial strain parameters
Exercise capacity (METs)
时间窗: 1 years
Functional capacity 1-15
NT-proBNP levels
时间窗: 1 yeqrs
Mg/dl
次要结局
- Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)(At time of most recent follow-up (minimum 3 months post-surgical repair))
研究者
Alaa Abdelrahman Abdelgaber Abdelhafez
Doctor
Assiut University
