Active — Not RecruitingNot Applicable

Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

Spain224 participantsStarted 2018-07-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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).

Timeframe: 4 years

Trial details

NCT IDNCT04737135

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-29

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