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Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

V

Vall d'Hebron University Hospital (HUVH)

Status

Unknown

Conditions

Fallot Tetralogy
Congenital Heart Defect
Congenital Heart Disease

Treatments

Other: Non intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04737135
PI 17/00149

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

224 participants in 1 patient group

Patients
Description:
Patients with Tetralogy of Fallot
Treatment:
Other: Non intervention

Trial contacts and locations

7

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Central trial contact

Laura Dos Subirá, MD, PhD

Data sourced from clinicaltrials.gov

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