Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

Cardiomyopathy Due to Drug Clinical Trial

Official title:

Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity: Clinical and Prognostic Implications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331806
• Other study ID #: IEO 398
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Daniela Cardinale, MD
• Phone: +39 0257489748
• Email: daniela.cardinale[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy Due to Drug
• Cardiotoxicity

Intervention

Diagnostic Test:
• Evaluation of myocardial fibrosis
echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Primary	Evaluation of blood levels of Galectin-3 (Gal-3)	Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis	1 month
Primary	Evaluation of Enhanced Liver Fibrosis score (ELF)	Evaluation of Enhanced Liver Fibrosis score (ELF) as biomarker of fibrosis	1 month
Primary	Evaluation of CMR imaging marker of fibrosis	Evaluation at CMR of Myocardial T1 before and after contrast media infusion and Myocardial extracellular volume	1 month
Secondary	Evaluation of response to heart failure treatment	the response to heart failure treatment in terms of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline	1 month
Secondary	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.	1 month
Secondary	Evaluation of levels of cytochrome C	cytochrome C is a marker of mitochondrial dysfunction	1 months