Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluation of blood levels of Galectin-3 (Gal-3)
Study Overview
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.
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at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Evaluation of myocardial fibrosis
Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent
Intervention: Evaluation of myocardial fibrosis (Diagnostic Test)
Outcomes
Primary Outcomes
Evaluation of blood levels of Galectin-3 (Gal-3)
Time Frame: 1 month
Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis
Evaluation of Enhanced Liver Fibrosis score (ELF)
Time Frame: 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
Time Frame: 1 month
Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2)
Time Frame: 1 month
Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) gene as biomarker of fibrosis
Secondary Outcomes
- Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline(1 month)
- Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP)(1 month)
- Evaluation of levels of cytochrome C(1 months)