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Early Assessment of Anthracycline-Induced Cardiotoxicity (CARDIOTOX)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Centre Henri Becquerel.   Recruitment status was  Not yet recruiting

First Received on September 12, 2005.   No Changes Posted
Sponsor: Centre Henri Becquerel
Collaborator: Ligue contre le cancer, France
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: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Early Assessment of Anthracycline-Induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Lymphoma
U.S. FDA Resources

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 Not yet recruiting
Rouen, France, 76038
Contact: Marc Thillays     +33 232 082 497     marc.thillays@rouen.fnclcc.fr    
Contact: Martine Ballot     +33 232 082 544     martine.ballot@rouen.fnclcc.fr    
Sub-Investigator: Hervé Tilly, MD            
Sub-Investigator: Stephane Lepretre, MD            
Sub-Investigator: Pascal Lenain, MD            
Sub-Investigator: Nathalie Contentin, MD            
Sub-Investigator: Aspasia Stamatoulas, MD            
Sub-Investigator: Pierre Vera, MD            
Sub-Investigator: Anne Hitzel, MD            
Principal Investigator: Fabrice Jardin, MD            
University Hospital of Rouen Not yet recruiting
Rouen, France, 76031
Contact: Jean Nicolas Dacher, MD     +33 232 888 990     Jean-Nicolas.Dacher@chu-rouen.fr    
Principal Investigator: Jean Nicolas Dacher, MD            
Sub-Investigator: Bruno Cauliez, MD            
Sub-Investigator: Alain Lavoinne, MD            
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
  More Information

Publications:
Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5.
Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. Review. No abstract available.
Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63.
Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9.

ClinicalTrials.gov Identifier: NCT00195897     History of Changes
Other Study ID Numbers: 2005-001-CHB
Study First Received: September 12, 2005
Last Updated: September 12, 2005
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:
Heart Failure
Lymphoma
Heart Diseases
Cardiovascular Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012



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