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Early Assessment of Anthracycline-Induced Cardiotoxicity (CARDIOTOX)

This study is not yet open for participant recruitment.
Study NCT00195897.   Last updated on September 12, 2005.   Information provided by Centre Henri Becquerel

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Descriptive Information Fields
Brief Title  Early Assessment of Anthracycline-Induced Cardiotoxicity (CARDIOTOX)
Official Title  Early Assessment of Anthracycline-Induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.
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.

Detailed Description
Study Phase
Study Type  Observational
Study Design  Screening, Longitudinal, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lymphoma
Heart Failure, Congestive
Intervention 
MEDLINE PMIDs 12075738,   9744975,   11279304,   12673177
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  40
Start Date  October 2005
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Alain Manrique, MD     +33 232 082 258     alain.manrique@univ-rouen.fr    
Contact: Marc Thillays     +33 232 082 497     marc.thillays@rouen.fnclcc.fr    
Location Countries  France
Administrative Information Fields
NCT ID  NCT00195897
Organization ID 2005-001-CHB
Secondary IDs ††
Study Sponsor  Centre Henri Becquerel
Collaborators †† Ligue contre le Cancer
Investigators 
Study Chair:     Alain Manrique, MD     Centre Henri Becquerel    
Principal Investigator:     Fabrice Jardin, MD     Centre Henri Becquerel    
Information Provided By Centre Henri Becquerel
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date September 12, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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