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Early Assessment of Anthracycline-Induced Cardiotoxicity (CARDIOTOX)
This study is not yet open for participant recruitment.
Verified by Centre Henri Becquerel, September 2005
First Received: September 12, 2005   No Changes Posted
Sponsor: Centre Henri Becquerel
Collaborator: Ligue contre le Cancer
Information provided by: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT00195897
  Purpose

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
Lymphoma
Heart Failure, Congestive

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Early Assessment of Anthracycline-Induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Estimated Enrollment: 40
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195897

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

Locations
France
Centre Henri Becquerel
Rouen, France, 76038
University Hospital of Rouen
Rouen, France, 76031
Sponsors and Collaborators
Centre Henri Becquerel
Ligue contre le Cancer
Investigators
Study Chair: Alain Manrique, MD Centre Henri Becquerel
Principal Investigator: Fabrice Jardin, MD Centre Henri Becquerel
  More Information

Publications:
Study ID Numbers: 2005-001-CHB
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00195897     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Henri Becquerel:
Lymphoma
Anthracyclines
Heart Failure
Radionuclide
Magnetic Resonance Imaging
Troponin
Natriuretic Peptide, Brain

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Heart Failure
Immunoproliferative Disorders
Neoplasms by Histologic Type
Heart Diseases
Immune System Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 30, 2009