NCT04737135

Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 224 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease
• Congenital Heart Defect
• Fallot Tetralogy

Interventions

Type	Name	Description
OTHER	Non intervention	Patients without intervention

Timeline

• Start date: 2018-07-09
• Primary completion: 2022-01-31
• Completion: 2022-06-30
• First posted: 2021-02-03
• Last updated: 2021-12-07

Locations

7 sites across 1 country: Spain