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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with Tetralogy of Fallot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non intervention | Other | Patients without intervention |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between myocardial fibrosis biomarkers and prior cardiac events (near-miss sudden death, supraventricular arrhythmias, ventricular arrhythmias and heart failure admissions). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18 years or older with repaired tetralogy of Fallot or double outlet right ventricle Fallot type
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain | ||
| Hospital Universitari Valle de Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28077469 | Background | 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. | |
| 27530825 | Background | 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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serum, plasma and genomic DNA from blood
| up to time of reparative surgery |
| Correlation between myocardial fibrosis assessed by cardiac magnetic resonance (T1-mapping) and other cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain). | 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). | Baseline |
| Correlation between serum collagen turnover biomarkers and cardiac magnetic resonance parameters (ventricular volumes, ejection fraction and strain) | 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). | Baseline |
| Correlation between myocardial fibrosis assessed by cardiac magnetic resonance (T1-mapping) and by serum collagen turnover biomarkers. | 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). | Baseline |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| 27390332 | Background | 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. |
| 22999338 | Background | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |