Clinical trial NCT00195897: Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)
Official title: Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphoma
Heart Failure, Congestive
Keywords: Lymphoma
Anthracyclines
Heart Failure
Radionuclide
Magnetic Resonance Imaging
Troponin
Natriuretic Peptide, Brain
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2005-09-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hodgkin lymphoma disease

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Alain Manrique, MD
role: STUDY_CHAIR
affiliation: Centre Henri Becquerel
name: Fabrice Jardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/annonc/mdf170.
citation: Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. doi: 10.1056/NEJM199809243391307. No abstract available.
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. doi: 10.1159/000046508.
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. doi: 10.1067/mnc.2003.7.