Clinical Trial

Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR

Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07010510
Lead Sponsor Assiut University
Conditions TOF
Enrollment 100 participants
Start Date 2025-06
Primary Completion 2029-05 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-08