An interventional study of Evaluation of myocardial fibrosis in Cardiomyopathy Due to Drug, sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by European Institute of Oncology · Not applicable, Interventional, and Diagnostic
This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment
The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.
Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) >10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.
All patients will undergo:
at time 0
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 100 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Diagnostic Test: Evaluation of myocardial fibrosis
echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
Time frame: 1 month
Evaluation of blood levels of Galectin-3 (Gal-3)
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
Time frame: 1 month
Evaluation of Enhanced Liver Fibrosis score (ELF)
Evaluation of Enhanced Liver Fibrosis score (ELF) as biomarker of fibrosis ELF score is a "marker set" constituted by 3 markers of fibrosis: lhyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of metalloproteinase 1, firstly utilized in the diagnosis and assessment of the severity of liver
Time frame: 1 month
Evaluation of CMR imaging marker of fibrosis
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
Time frame: 1 month
Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
evaluation of the response to heart failure treatment in terms of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline
Time frame: 1 month
Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)
Troponin I (TnI) and B-type Natriuretic Peptide (BNP) are biomarkers already utilized in the early diagnosis and monitoring of AIC and recognized prognostic indexes in patients with heart failure.
Time frame: 1 month
Evaluation of levels of cytochrome C
cytochrome C is a marker of mitochondrial dysfunction
Time frame: 1 months
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European Institute of Oncology