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

NCT07010510 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • TOF

Interventions

DIAGNOSTIC_TEST

CMR, stress ECG, Holter, BnP

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2029-05-31
Completion
2030-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010510 on ClinicalTrials.gov