Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

Not Applicable

Recruiting

• Conditions: Cardiomyopathy Due to Drug
• Interventions: Diagnostic Test: Evaluation of myocardial fibrosis

• Registration Number: NCT06331806
• Lead Sponsor: European Institute of Oncology

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).

Study Timeline

• Study Start: 2018-02-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-26
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of myocardial fibrosis	Evaluation of myocardial fibrosis	Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy