Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

NCT ID: NCT00195897

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma Heart Failure, Congestive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Manrique, MD

Role: STUDY_CHAIR

Centre Henri Becquerel

Fabrice Jardin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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University Hospital of Rouen

Rouen, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 12075738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9744975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11279304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12673177 (View on PubMed)

Other Identifiers

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2005-001-CHB

Identifier Type: -

Identifier Source: org_study_id

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