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NCT04737135 - Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

Official Title
Interstitial Myocardial Fibrosis in Repaired Tetralogy of Fallot: Assessment by Molecular and Imaging Biomarkers and Association With Adverse Events ( Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)
Brief Title
Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)
Protocol ID
NCT04737135
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Brief Summary
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.
Detailed Description
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.
Study Period
-
Enrollment Count
224 participants
Eligibility Criteria
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.
Filters
Congenital Heart Disease
Congenital Heart Defect
Fallot Tetralogy
UNKNOWN
ADULT
OLDER_ADULT