NOT YET RECRUITING
NCT07010510
Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR
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.
Gender: All
Ages: 18 Years - Any
