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

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

Tracking Information

• First Submitted Date: January 20, 2021
• First Posted Date: February 3, 2021
• Last Update Posted Date: December 7, 2021
• Actual Study Start Date: July 9, 2018
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2021)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 2, 2021)

• 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)
• 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).
• 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).
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)
• 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)
• 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.
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 4 Years

Biospecimen

Retention:   Samples With DNA

Description:

serum, plasma and genomic DNA from blood

• Sampling Method: Probability Sample
• Study Population: Patients aged 18 years or older with repaired tetralogy of Fallot or double outlet right ventricle Fallot type

Condition

• Congenital Heart Disease
• Congenital Heart Defect
• Fallot Tetralogy

Intervention

Other: Non intervention

Patients without intervention

Other Name: Patients without intervention

Study Groups/Cohorts

Patients

Patients with Tetralogy of Fallot

Intervention: Other: Non intervention

Publications *

• Oliver JM, Gallego P, Gonzalez AE, Garcia-Hamilton D, Avila P, Yotti R, Ferreira I, Fernandez-Aviles F. Risk factors for excess mortality in adults with congenital heart diseases. Eur Heart J. 2017 Apr 21;38(16):1233-1241. doi: 10.1093/eurheartj/ehw590.
• Stefanescu Schmidt AC, DeFaria Yeh D, Tabtabai S, Kennedy KF, Yeh RW, Bhatt AB. National Trends in Hospitalizations of Adults With Tetralogy of Fallot. Am J Cardiol. 2016 Sep 15;118(6):906-911. doi: 10.1016/j.amjcard.2016.06.034. Epub 2016 Jun 27.
• Puntmann VO, Peker E, Chandrashekhar Y, Nagel E. T1 Mapping in Characterizing Myocardial Disease: A Comprehensive Review. Circ Res. 2016 Jul 8;119(2):277-99. doi: 10.1161/CIRCRESAHA.116.307974.
• Chen CA, Tseng WY, Wang JK, Chen SY, Ni YH, Huang KC, Ho YL, Chang CI, Chiu IS, Su MY, Yu HY, Lin MT, Lu CW, Wu MH. Circulating biomarkers of collagen type I metabolism mark the right ventricular fibrosis and adverse markers of clinical outcome in adults with repaired tetralogy of Fallot. Int J Cardiol. 2013 Sep 10;167(6):2963-8. doi: 10.1016/j.ijcard.2012.08.059. Epub 2012 Sep 19.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 2, 2021): 224
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2022
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04737135
• Other Study ID Numbers: PI 17/00149
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital Universitari Vall d'Hebron Research Institute
• Verification Date: December 2021