Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

NCT04737135 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Phase

Observational

Started

2018-07-09

Last updated

2026-04-29

Condition(s) studied

Congenital Heart DiseaseCongenital Heart DefectFallot Tetralogy

Investigational drug(s) / intervention(s)

Non intervention

Non intervention: Patients without intervention

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

Correlation between myocardial fibrosis biomarkers and a composite of cardiac adverse events (cardiovascular death, sudden cardiac death, near-miss sudden death, supraventricular arrhythmias, ventricular arrhythmias, heart failure). — 4 years
Myocardial fibrosis biomarkers: Cardiac Magnetic Resonance T1-mapping (extracellular volume fraction) and serum collagen turnover biomarkers (C-terminal propeptide of type I procollagen, C-terminal Telopeptide of type I Collagen, Matrix Metalloproteinase 1 and Tissue Inhibitor of Metalloproteinases-1)

Trial sites (7)

Facility	City	Region
Hospital Universitario 12 de Octubre	Madrid	Madrid
Hospital Universitari Valle de Hebron	Barcelona	Spain
Hospital Clínic i Provincial de Barcelona	Barcelona	Spain
Hospital General Universitario Gregorio Marañón	Madrid	Spain
Hospital Universitario La Paz	Madrid	Spain
Hospital Universitario Virgen del Rocío	Seville	Spain
Hospital Universitario y Politécnico La Fe	Valencia	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04737135 on ClinicalTrials.gov ↗ ← All trials in Spain