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

N/ANot Yet RecruitingNCT07010510

Assiut University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

TOF

Interventions

This study involves no experimental intervention. All data were collected retrospectively from patients with repaired Tetralogy of Fallot (TOF) who underwent standard clinical follow-up. As part of routine care, patients received comprehensive multimodal functional assessment, including: Cardiac Magnetic Resonance Imaging (CMR) with feature-tracking strain analysis Transthoracic Echocardiography Exercise stress testing (treadmill ECG using Bruce protocol) 12-lead ECG and 24-hour Holter monitoring Laboratory evaluation including NT-proBNP levels NYHA functional class assessment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* Inclusion criteria: * Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft). * Adults (age ≥18 years) with repaired TOF. * Undergoing routine CMR for clinical follow-up. * Sinus rhythm or known history of ventricular arrhythmia. * Exclusion criteria: * Confounding other congenital defects e.g. AV canal. * Significant aortic regurgitation or stenosis. * Significant mitral regurgitation. * Residual significant major aorto-pulmonary collaterals (MAPCAs). * Patients with contraindications to CMR (e.g., pacemakers, severe renal impairment, claustrophobic). * Poor-quality CMR images precluding strain analysis.

Outcomes

Primary Outcomes

NYHA Class

New York Heart Association (NYHA) classification 1 to 4

Time frame: 1 year

cardiac magnetic resonance (CMR)

myocardial strain parameters

Time frame: 1 years

Exercise capacity (METs)

Functional capacity 1-15

Time frame: 1 years

NT-proBNP levels

Mg/dl

Time frame: 1 yeqrs

Secondary Outcomes

Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)

Identification and documentation of arrhythmias based on standard 12-lead ECG and 24-hour Holter monitoring. Includes detection of premature ventricular contractions (PVCs), sustained or non-sustained ventricular tachycardia (VT), atrial flutter, atrial fibrillation, or other clinically significant arrhythmias requiring intervention.

Time frame: At time of most recent follow-up (minimum 3 months post-surgical repair)