Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study) (FIFA)
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ClinicalTrials.gov Identifier: NCT04737135 |
Recruitment Status : Unknown
Verified December 2021 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was: Recruiting
First Posted : February 3, 2021
Last Update Posted : December 7, 2021
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Condition or disease | Intervention/treatment |
---|---|
Congenital Heart Disease Congenital Heart Defect Fallot Tetralogy | Other: Non intervention |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Patients
Patients with Tetralogy of Fallot
|
Other: Non intervention
Patients without intervention
Other Name: Patients without intervention |
- 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)
- 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).
Biospecimen Retention: Samples With DNA
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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 |
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.
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
Contact: Laura Dos Subirá, MD, PhD | +34932746170 | ldos@vhebron.net |
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 |
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 |
Fallot Tetralogy Myocardial fibrosis T1-mapping Collagen turnover biomarkers |
Heart Diseases Heart Defects, Congenital Tetralogy of Fallot Fibrosis |
Pathologic Processes Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |