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

NCT01212926 | Completed

• 1 other identifier: CHUBX 2009/23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Cardiac Toxicity

Outcome Measures

Primary Outcomes (5)

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

  6 weeks

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

  3 months

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

  6 months

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

  9 months

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

  12 months

Secondary Outcomes (5)

• determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 weeks of anthracycline chemotherapy.

  6 weeks

• determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 3 months of anthracycline chemotherapy.

  3 months

• determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 6 months of anthracycline chemotherapy.

  6 months

• determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 9 months of anthracycline chemotherapy.

  9 months

• determination of radial and circumferential myocardial deformation by echography with 2D strain analysis after 12 months of anthracycline chemotherapy.

  12 months

Study Arms (1)

analysis of myocardial deformation in 2D strain

EXPERIMENTAL

Device: Echographic analysis of myocardial deformation in 2D strain

Interventions

Echographic analysis of myocardial deformation in 2D strain DEVICE

analysis of myocardial deformation in 2D strain

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Leukemia; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Stéphane Lafitte, MD-PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: September 28, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 25, 2015
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

FR (1)