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
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Cardiotoxicity Revealed by TnI Increase.
Drug: oral enalapril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • Incidence of chemotherapy-induced cardiotoxicity

Secondary Outcome Measures:
  • Major adverse cardiac events, including death.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292526

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Study Director: Carlo M Cipolla, MD European Institute of Oncology
Principal Investigator: Daniela Cardinale, MD European Institute of Oncology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00292526     History of Changes
Other Study ID Numbers: IEO S67/500
Study First Received: February 15, 2006
Last Updated: February 15, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by European Institute of Oncology:
Chemotherapy-induced cardiotoxicity
Troponin
Heart failure

Additional relevant MeSH terms:
Enalapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014