Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathy Due to Drug
• Intervention / Treatment: Diagnostic test: Evaluation of myocardial fibrosis

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Cardinale, MD; Phone Number: +39 0257489748; Email: daniela.cardinale@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Daniela Cardinale, MD; Email: daniela.cardinale@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Evaluation of myocardial fibrosis; Echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent	Diagnostic test: Evaluation of myocardial fibrosis; echocardiogram with left ventricular ejection fraction (LVEF) evaluation (biplane method) and CMR with contrast media agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of blood levels of Galectin-3 (Gal-3)	Evaluation of blood levels of Galectin-3 (Gal-3) as biomarker of fibrosis	1 month
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
Evaluation of Enhanced Liver Fibrosis score (ELF)	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of levels of cytochrome C	cytochrome C is a marker of mitochondrial dysfunction	1 months
Evaluation of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline	evaluation of the response to heart failure treatment in terms of improvement in left ventricular ejection fraction (LVEF) absolute points from baseline	1 month

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Daniela Cardinale, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiomyopathies; Cardiotoxicity
• Other Study ID Numbers: IEO 398

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No