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Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT00292526
First received: February 15, 2006
Last updated: February 7, 2017
Last verified: February 2017
February 15, 2006
February 7, 2017
November 2000
November 2011   (Final data collection date for primary outcome measure)
Incidence of chemotherapy-induced cardiotoxicity [ Time Frame: 12 month period ]
Incidence of chemotherapy-induced cardiotoxicity
Complete list of historical versions of study NCT00292526 on ClinicalTrials.gov Archive Site
Major adverse cardiac events, including death. [ Time Frame: 12 month period ]
Major adverse cardiac events, including death.
Not Provided
Not Provided
 
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
  • Cardiotoxicity
  • Chemotherapeutic Toxicity
Drug: Enalapril
enalapril orally administered
Experimental: enalapril arm
treatment with enalapril
Intervention: Drug: Enalapril

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00292526
IEO S67/500
Not Provided
Not Provided
No
Not Provided
European Institute of Oncology
European Institute of Oncology
Not Provided
Study Director: Carlo M Cipolla, MD European Institute of Oncology
Principal Investigator: Daniela Cardinale, MD European Institute of Oncology
European Institute of Oncology
February 2017

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