Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

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

UNKNOWN

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-09

Study Completion Date

2022-06-30

Brief Summary

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

This study aims to study the correlation between biomarkers of myocardial fibrosis (extracellular volume fraction calculated by cardiac magnetic resonance imaging (MRI) (T1-mapping) and levels of molecular biomarkers of fibrosis) and adverse events in a population of patients with repaired tetralogy of Fallot.

Related Clinical Trials

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

Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy

NCT03415789

Dilated Cardiomyopathy Thrombosis Stroke

COMPLETED

Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

NCT02885883

Atrial Fibrillation

COMPLETED NA

Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery

NCT02551588

Aortic Valve Stenosis

COMPLETED

Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI

NCT00489788

Congenital Disorders

COMPLETED

Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

NCT03422770

Aortic Valve Stenosis Myocardial Fibrosis

COMPLETED NA

Detailed Description

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

The main causes of mortality in adults with repaired tetralogy of Fallot (TF) are sudden death and heart failure. Myocardial fibrosis has been linked to the appearance of arrhythmias and ventricular dysfunction in other patient populations, but this association is poorly studied in patients with TF, perhaps because research in congenital heart disease (CHD) requires multicenter studies, difficult to carry out. Interstitial myocardial fibrosis assessed by molecular and imaging biomarkers is associated with adverse events in patients with repaired Fallot tetralogy.

Conditions

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

Congenital Heart Disease Congenital Heart Defect Fallot Tetralogy

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

PROSPECTIVE

Study Groups

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

Patients

Patients with Tetralogy of Fallot

Non intervention

Intervention Type OTHER

Patients without intervention

Interventions

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

Non intervention

Patients without intervention

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patients without intervention

Eligibility Criteria

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

Inclusion Criteria

* Patients aged 18 years or older with repaired tetralogy of Fallot or double outlet right ventricle Fallot type

Exclusion Criteria

* Patients with pathologies that may interfere with the determination of the extracellular volume of myocardium (ischemic heart disease, storage diseases).
* Patients with pathologies that affect collagen metabolism (liver cirrhosis, stage ≥4 renal insufficiency, pulmonary fibrosis, metabolic bone disease, connective tissue diseases, active neoplasms, active treatment with corticosteroids and bone fractures or surgery in the previous 6 months).
* Pregnancy.
* Denial of informed consent.
* Patients with claustrophobia and pacemakers or defibrillators.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No