Cardiomyopathy Due to Drug
Conditions
Brief summary
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
Detailed description
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 * an echocardiogram with LVEF evaluation (biplane method) * a single blood sample. * at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).
Interventions
DIAGNOSTIC_TESTEvaluation of myocardial fibrosis
echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.
Exclusion criteria
* Age \<18 years * Contraindications to contrast medium magnetic resonance imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) | 1 month | Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis |
| Evaluation of blood levels of Galectin-3 (Gal-3) | 1 month | Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis |
| Evaluation of Enhanced Liver Fibrosis score (ELF) | 1 month | 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 |
| Evaluation of CMR imaging marker of fibrosis | 1 month | Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP) | 1 month | 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. |
| Evaluation of levels of cytochrome C | 1 months | cytochrome C is a marker of mitochondrial dysfunction |
| Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline | 1 month | evaluation of the response to heart failure treatment in terms of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline |
Countries
Italy
Contacts
Primary ContactDaniela Cardinale, MD
Outcome results
None listed