Cardiovascular DiseasesAnthracardioNCT02875171
Assessment of Global Longitudinal Strain for the Prediction of Anthracycline Induced Cardiotoxicity
An observational study of Cardiovascular Diseases, run by Versailles Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Anthracycline administration
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included
Who may be able to join
- patients suffering from lymphoma or leukemia and requiring anthracycline therapy;
- over 18 years old;
- baseline LVEF >50%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Global Longitudinal Strain at Low Dose Anthracycline-based Chemotherapy for the Prediction of Subsequent Cardiotoxicity
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.
Read more
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.
Read the detailed description
Study population:
This is a single-centre, prospective cohort study. The patients are evaluated at four time points: visit 1 (V1), before the initiation of anthracycline therapy; visit 2 (V2), after reaching a cumulative dose of 150 mg/m²; visit 3 (V3), at the end of the treatment; and visit 4 (V4), 1 year after V1.
Clinical examination at each visit and standard echocardiography are performed. The study is approved by our ethics committee (EudraCT number 2011-002721- 22).
Two-dimensional echocardiography:
Echocardiography examinations are performed using a Vivid E9 imaging device (GE Medical systems, Horten, Norway). The left ventricular end-diastolic and endsystolic volumes are measured from the apical two- and four-chamber views; LVEF are calculated using Simpson's rule. GLS is computed from high frame rate (>50 frames per second) apical views (four-, two-, and three-chamber). By tracing the endocardial borders on an end-systolic frame, myocardial speckles are automatically tracked on the subsequent frames. Adequate tracking is verified, and manually corrected if necessary. GLS is obtained as the average of regional strains. Percentage change in GLS and absolute reduction in GLS are calculated between baseline and V2. Other classic diastolic and systolic parameters are recorded according to current guidelines. Digital loops are stored for off-line analysis. For LVEF and GLS, digital loops are done in triplicate to assess inter- and intraobserver variability. LVEF and GLS are analysed by two readers. The readers are blinded to each other's measurements and to the patient visit number.
Echocardiographic definition of AIC:
According to a recent consensus paper, anthracycline cardiotoxicity is defined as a decrease in the LVEF of >10 percentage points, to a value <53%, at V4. This decrease has to be confirmed by a repeat echocardiography performed a few weeks after V4.
- Conditions
- Cardiovascular Diseases
- Being tested
- Anthracycline administration
- Keywords
- Anthracyclines; Cardiotoxicity; 2-D Echocardiography
- Medical subject headings
- Cardiovascular Diseases, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthracycline administrationDrug
Also called Anthracycline
Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included
| Study group | Role | What they receive |
|---|---|---|
| Anthracycline therapy | Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included Receives: Drug: Anthracycline administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes in Global Longitudinal Strain (GLS) throughout the visits
Determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startOct 2011
- Primary completionMay 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clément Charbonnel, Versailles Hospital
- Investigators
- Charbonnel Clément, MD, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875171
- Sponsor's protocol ID
- 11/17_Anthracardio
- Acronym
- Anthracardio
- Status last verified
- Jan 2017
- First submitted
- 11 Aug 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Global Longitudinal Strain at Low Dose Anthracycline-based Chemotherapy for the Prediction of Subsequent Cardiotoxicity
- ClinicalTrials.gov ID
- NCT02875171
- Acronym / sponsor ID
- Anthracardio / 11/17_Anthracardio
- Conditions
- Cardiovascular Diseases
- Keywords
- Anthracyclines; Cardiotoxicity; 2-D Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study population:
This is a single-centre, prospective cohort study. The patients are evaluated at four time points: visit 1 (V1), before the initiation of anthracycline therapy; visit 2 (V2), after reaching a cumulative dose of 150 mg/m²; visit 3 (V3), at the end of the treatment; and visit 4 (V4), 1 year after V1.
Clinical examination at each visit and standard echocardiography are performed. The study is approved by our ethics committee (EudraCT number 2011-002721- 22).
Two-dimensional echocardiography:
Echocardiography examinations are performed using a Vivid E9 imaging device (GE Medical systems, Horten, Norway). The left ventricular end-diastolic and endsystolic volumes are measured from the apical two- and four-chamber views; LVEF are calculated using Simpson's rule. GLS is computed from high frame rate (>50 frames per second) apical views (four-, two-, and three-chamber). By tracing the endocardial borders on an end-systolic frame, myocardial speckles are automatically tracked on the subsequent frames. Adequate tracking is verified, and manually corrected if necessary. GLS is obtained as the average of regional strains. Percentage change in GLS and absolute reduction in GLS are calculated between baseline and V2. Other classic diastolic and systolic parameters are recorded according to current guidelines. Digital loops are stored for off-line analysis. For LVEF and GLS, digital loops are done in triplicate to assess inter- and intraobserver variability. LVEF and GLS are analysed by two readers. The readers are blinded to each other's measurements and to the patient visit number.
Echocardiographic definition of AIC:
According to a recent consensus paper, anthracycline cardiotoxicity is defined as a decrease in the LVEF of >10 percentage points, to a value <53%, at V4. This decrease has to be confirmed by a repeat echocardiography performed a few weeks after V4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anthracycline therapy | – | Drug: Anthracycline administrationPatients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included
Key inclusion criteria (3 listed)
- patients suffering from lymphoma or leukemia and requiring anthracycline therapy;
- over 18 years old;
- baseline LVEF >50%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthracycline administrationAlso: AnthracyclinePatients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included | Drug | Anthracycline therapy |
Primary outcome
Dynamic changes in Global Longitudinal Strain (GLS) throughout the visits
Time frame: 1 year
Determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charbonnel Clément, MD principal investigator
CH Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes in Global Longitudinal Strain (GLS) throughout the visits (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.