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Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study) (FIFA)

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ClinicalTrials.gov Identifier: NCT04737135
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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 molecular biomarkers of fibrosis) and adverse events in a population of patients with repaired tetralogy of Fallot.

Condition or disease Intervention/treatment
Congenital Heart Disease Congenital Heart Defect Fallot Tetralogy Other: Non intervention

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 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Interstitial Myocardial Fibrosis in Repaired Tetralogy of Fallot: Assessment by Molecular and Imaging Biomarkers and Association With Adverse Events ( Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
Patients with Tetralogy of Fallot
Other: Non intervention
Patients without intervention
Other Name: Patients without intervention




Primary Outcome Measures :
  1. 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). [ Time Frame: 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)


Secondary Outcome Measures :
  1. Correlation between myocardial fibrosis biomarkers and prior cardiac events (near-miss sudden death, supraventricular arrhythmias, ventricular arrhythmias and heart failure admissions). [ Time Frame: up to time of reparative surgery ]
    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)

  2. Correlation between myocardial fibrosis assessed by cardiac magnetic resonance (T1-mapping) and other cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain). [ Time Frame: Baseline ]
    Correlation of myocardial fibrosis assessed by cardiac magnetic resonance T1-mapping (extracellular volume fraction) and other cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain).

  3. Correlation between serum collagen turnover biomarkers and cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain) [ Time Frame: Baseline ]
    Correlation between 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) and cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain).

  4. Correlation between myocardial fibrosis assessed by cardiac magnetic resonance (T1-mapping) and by serum collagen turnover biomarkers. [ Time Frame: Baseline ]
    Correlation of myocardial fibrosis assessed by cardiac magnetic resonance T1-mapping (extracellular volume fraction) and by serum collagen turnover biomarkers (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).


Biospecimen Retention:   Samples With DNA
serum, plasma and genomic DNA from blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged 18 years or older with repaired tetralogy of Fallot or double outlet right ventricle Fallot type
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737135


Contacts
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Contact: Laura Dos Subirá, MD, PhD +34932746170 ldos@vhebron.net

Locations
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Spain
Hospital Universitari Valle de Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Publications:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04737135    
Other Study ID Numbers: PI 17/00149
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Fallot Tetralogy
Myocardial fibrosis
T1-mapping
Collagen turnover biomarkers
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Tetralogy of Fallot
Fibrosis
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities