Prevention of Chemotherapy-Induced Cardiotoxicity in High-Risk Patients

This study has been completed.
Sponsor:
Information provided by:
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT00292526
First received: February 15, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

February 15, 2006
February 15, 2006
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Incidence of chemotherapy-induced cardiotoxicity
Same as current
No Changes Posted
Major adverse cardiac events, including death.
Same as current
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Prevention of Chemotherapy-Induced Cardiotoxicity in High-Risk Patients
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In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of CTIC. We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in high-risk cancer patients.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Chemotherapy-Induced Cardiotoxicity Revealed by TnI Increase.
Drug: oral enalapril
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I

Exclusion Criteria:

  • Contraindication to ACE-inhibitors
  • On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers
Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00292526
IEO S67/500
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European Institute of Oncology
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Study Director: Carlo M Cipolla, MD European Institute of Oncology
Principal Investigator: Daniela Cardinale, MD European Institute of Oncology
European Institute of Oncology
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP