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TerminatedNCT00195897Updated Aug 22, 2016

Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

An observational study in Lymphoma and Heart Failure, Congestive, sponsored by Centre Henri Becquerel. Terminated at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-22.

Sponsored by Centre Henri Becquerel · Observational

Why this study was terminated
No patients; only 6 enrolled after 2 years
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Lymphoma
  • Heart Failure, Congestive

Keywords

  • Lymphoma
  • Anthracyclines
  • Heart Failure
  • Radionuclide
  • Magnetic Resonance Imaging
  • Troponin
  • Natriuretic Peptide, Brain
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 6 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hodgkin lymphoma disease

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)
06

Study locations

2 sites
  • University Hospital of Rouen
    Rouen, 76031, France
  • Centre Henri Becquerel
    Rouen, 76038, France
07

References and documents

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. doi: 10.1093/annonc/mdf170. PubMed 12075738 ↗
  • 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. PubMed 9744975 ↗
  • 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. PubMed 11279304 ↗
  • 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. PubMed 12673177 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00195897
Lead sponsor
Centre Henri Becquerel
Collaborators
Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Jan 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Aug 22, 2016

Study contacts

Alain Manrique, MD
study chair · Centre Henri Becquerel
Fabrice Jardin, MD
principal investigator · Centre Henri Becquerel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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