Assessment of Global Longitudinal Strain for the Prediction of Anthracycline Induced Cardiotoxicity

NCT02875171 | Completed

• 1 other identifier: 11/17_Anthracardio
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure treatment can potentially reverse cardiac dysfunction at the early stage of cardiac toxicity, early detection of AIC is crucial. Transthoracic echocardiography is recommended for monitoring left ventricular function in patients receiving these molecules. In routine practice, left ventricular systolic function is mainly assessed by the left ventricular ejection fraction (LVEF), measured by two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience and is not sensitive enough to detect subclinical myocardial dysfunction. To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed. This technique allows for a study of global and regional myocardial deformation, especially the longitudinal component, which appears to be the most sensitive one. Several studies have already emphasized the role of global longitudinal strain (GLS) to detect slight alterations in systolic function, especially in the setting of potentially cardiotoxic drugs and even after low to moderate doses of anthracyclines. A recent expert consensus paper strongly recommends GLS assessment for the detection of subclinical left ventricular dysfunction due to anthracycline therapy. Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few data exist on the optimal timing to perform echocardiography. The investigators hypothesized that very early measurement of GLS in the time course of anthracycline therapy could predict subsequent left ventricular systolic dysfunction. The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.

Conditions

Cardiovascular Diseases

Keywords

Anthracyclines; Cardiotoxicity; 2-D Echocardiography

Outcome Measures

Primary Outcomes (1)

• Dynamic changes in Global Longitudinal Strain (GLS) throughout the visits

  Determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.

  1 year

Study Arms (1)

Anthracycline therapy

Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included

Drug: Anthracycline administration

Interventions

Anthracycline administration DRUG

Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included

Also known as: Anthracycline

Anthracycline therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included

You may qualify if:

• patients suffering from lymphoma or leukemia and requiring anthracycline therapy;
• over 18 years old;
• baseline LVEF \>50%.

You may not qualify if:

• moderate to severe aortic or mitral valve disease;
• pregnant or breastfeeding women;
• atrial fibrillation;
• very poor image quality defined by two or more myocardial segments inadequately visualized (17-segment model);
• unstable cardiac condition such as pericardial effusion or acute coronary syndrome.

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

CH Versailles

Le Chesnay, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiotoxicity

Interventions

Anthracyclines

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Charbonnel Clément, MD

  CH Versailles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study principal investigator

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 23, 2016
• Study Start: October 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)