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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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