Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

Lymphoma Clinical Trial

Official title:

Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00195897
• Other study ID #: 2005-001-CHB
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 19, 2016
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2016
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiotoxicity
• Heart Failure
• Heart Failure, Congestive
• Lymphoma

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen
France	University Hospital of Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Henri Becquerel	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. Review. — View Citation