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Clinical Trials/NCT07010510
NCT07010510Not yet recruitingNot Applicable

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

Assiut University0 sites100 target enrollmentStarted: June 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
NYHA Class

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

NYHA Class

Time Frame: 1 year

New York Heart Association (NYHA) classification 1 to 4

cardiac magnetic resonance (CMR)

Time Frame: 1 years

myocardial strain parameters

Exercise capacity (METs)

Time Frame: 1 years

Functional capacity 1-15

NT-proBNP levels

Time Frame: 1 yeqrs

Mg/dl

Secondary Outcomes

  • Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)(At time of most recent follow-up (minimum 3 months post-surgical repair))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alaa Abdelrahman Abdelgaber Abdelhafez

Doctor

Assiut University

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