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NCT Number: 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.

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Key information

Conditions

TOF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

CMR, stress ECG, Holter, BnP

Diagnostic Test

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

Primary outcomes

  1. NYHA Class

    Time frame: 1 year

    New York Heart Association (NYHA) classification 1 to 4

  2. cardiac magnetic resonance (CMR)

    Time frame: 1 years

    myocardial strain parameters

  3. Exercise capacity (METs)

    Time frame: 1 years

    Functional capacity 1-15

  4. NT-proBNP levels

    Time frame: 1 yeqrs

    Mg/dl

Secondary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa AA Abdelhafez

CONTACT

[email protected]

01140522334

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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