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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2030-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Changes in Fluid Status on Right Ventricular Volumes and Function

NCT02967315

Tetralogy of Fallot

COMPLETED NA

Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot

NCT00564993

Tetralogy of Fallot

TERMINATED PHASE3

Asynchrony in Operated Tetralogy of Fallot

NCT05485545

Tetralogy of Fallot

UNKNOWN NA

Myocardial Biopsy in Congenital Cardiac Surgery

NCT03595111

Myocardial Protection

UNKNOWN NA

Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery

NCT04657835

Postoperative Atrial Fibrillation

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

TOF

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with TOF

The study cohort consists of adult patients (≥18 years) with previously repaired Tetralogy of Fallot (TOF) who underwent routine clinical follow-up, including cardiac imaging, functional testing, and laboratory investigations. Patients included underwent surgical repair using either valve-sparing techniques or valved conduits and had follow-up assessments performed at least 3 months post-surgery. Data will be retrospectively collected from medical records, imaging databases, and clinical documentation. The cohort includes patients in sinus rhythm or with a documented history of ventricular arrhythmia, all of whom were referred for routine cardiovascular magnetic resonance (CMR) imaging and other functional assessments as part of standard care.

CMR, stress ECG, Holter, BnP

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No