Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

Sponsor
Centre Henri Becquerel (Other)
Overall Status
Terminated
CT.gov ID
NCT00195897
Collaborator
Ligue contre le cancer, France (Other)
6
2
47
3
0.1

Study Details

Study Description

Brief Summary

Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.

The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.
    Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Histologically proven lymphoma (Hodgkin's or non-Hodgkin's)

      • Age > 18 y/o and < 70 y/o

      • WHO score < or = 2

      • Life expectancy > 6 mo

      • Left ventricular ejection fraction > 50%

      • Informed consent

      Exclusion Criteria:
      • Previous chemotherapy using anthracyclines

      • History of radiation therapy

      • History of congestive heart failure

      • History of chronic renal insufficiency

      • Contra indication to MR examination

      • Atrial fibrillation and significant arrhythmia

      • Pregnancy

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital of Rouen Rouen France 76031
      2 Centre Henri Becquerel Rouen France 76038

      Sponsors and Collaborators

      • Centre Henri Becquerel
      • Ligue contre le cancer, France

      Investigators

      • Study Chair: Alain Manrique, MD, Centre Henri Becquerel
      • Principal Investigator: Fabrice Jardin, MD, Centre Henri Becquerel

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Centre Henri Becquerel
      ClinicalTrials.gov Identifier:
      NCT00195897
      Other Study ID Numbers:
      • 2005-001-CHB
      First Posted:
      Sep 20, 2005
      Last Update Posted:
      Aug 22, 2016
      Last Verified:
      Aug 1, 2016
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Keywords provided by Centre Henri Becquerel
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 22, 2016