Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

European Institute of Oncology

Status: Enrolling

Conditions: Cardiomyopathy Due to Drug

Treatments: Diagnostic Test: Evaluation of myocardial fibrosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06331806

IEO 398

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Evaluation of myocardial fibrosis

Other group

Description:

Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Treatment:

Diagnostic Test: Evaluation of myocardial fibrosis