CompletedNot Applicable

Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain

France100 participantsStarted 2010-09-28

Plain-language summary

It is now accepted that the anticancer properties of anthracyclines were allowed in many malignancies improve the prognosis of affected populations. However, the cardiotoxicity of anthracyclines is responsible for an interruption of this treatment by alteration of potentially irreversible myocardial contraction and high mortality. An earlier detection of adverse myocardial anthracycline chemotherapy would allow the adaptation of the regimen by reducing the number of interruptions of antitumor and strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in survival of patients treated.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient female or male aged between 18 and 65 * Patients with a haematological disease and ran for a first-line chemotherapy including anthracycline * Patients with a predict cardiovascular score to 10 years below 20% or if higher, with a stress echocardiography using dobutamine, negative, for less than six months. * Patient or affiliate receiving social security * Patient informed consent and having oral and written Exclusion Criteria: * A history of chemotherapy or radiotherapy of the left hemithorax * Significant coronary artery disease: a history of angioplasty, stent, CABG, predict cardiovascular score to 10 years over 20% of stress echocardiography and dobutamine positive (three positive segments) * Left ventricular hypertrophy (diastolic septum ≥ 10 mm and diastolic posterior wall ≥ 10 mm) * One or more significant valvulopathy: Rao, RM medium or tight, IM, IT and CAI ≥ grade 2 * Secondary or primary cardiomyopathy (LVEF ≤ 50%) * Pregnant or lactating

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has already been completed, has my doctor seen or reviewed the findings about whether 2D strain echocardiography can detect early heart damage during anthracycline chemotherapy, and could those results influence how my heart is monitored during my own leukemia treatment?
2If anthracyclines are part of my treatment plan, would my doctor consider using 2D strain echocardiography — the specific heart-monitoring technique studied in this trial — to watch for early signs of cardiac toxicity, rather than waiting for more obvious changes to show up on a standard echocardiogram?
3This trial tracked heart function at 6 weeks, 3 months, 6 months, 9 months, and 12 months after starting anthracycline chemotherapy — is that kind of regular, long-term cardiac monitoring something my care team would do for me, and what would happen if a problem was detected at one of those checkpoints?
4Given that this trial specifically focused on leukemia patients receiving anthracyclines, how concerned should I be about the risk of cardiotoxicity from my chemotherapy, and are there ways to reduce that risk while still treating my leukemia effectively?
5Are there standard cardiac monitoring guidelines already in place for anthracycline treatment that my care team follows, and does the evidence from completed studies like this one change or improve what would normally be recommended for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.

Timeframe: 6 weeks

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.

Timeframe: 3 months

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.

Timeframe: 6 months

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.

Timeframe: 9 months

determination of longitudinal myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.

Timeframe: 12 months

Trial details

NCT IDNCT01212926

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

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