Early Assessment of Anthracycline-Induced Cardiotoxicity (CARDIOTOX) - Full Text View

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:

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
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:

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.

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