Status:

UNKNOWN

Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

Lead Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Conditions:

Congenital Heart Disease

Congenital Heart Defect

Eligibility:

All Genders

18+ years

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 mole...

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 d...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

July 9 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2022

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT04737135

Start Date

July 9 2018

End Date

June 30 2022

Last Update

December 7 2021

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Hospital Universitari Valle de Hebron

Barcelona, Spain, 08035

2

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

3

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

4

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041