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Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

This study has been completed.
Information provided by (Responsible Party):
European Institute of Oncology Identifier:
First received: February 15, 2006
Last updated: February 7, 2017
Last verified: February 2017
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
Cardiotoxicity Chemotherapeutic Toxicity Drug: Enalapril Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Resource links provided by NLM:

Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • Incidence of chemotherapy-induced cardiotoxicity [ Time Frame: 12 month period ]

Secondary Outcome Measures:
  • Major adverse cardiac events, including death. [ Time Frame: 12 month period ]

Enrollment: 114
Actual Study Start Date: November 2000
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enalapril arm
treatment with enalapril
Drug: Enalapril
enalapril orally administered


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00292526

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

Responsible Party: European Institute of Oncology Identifier: NCT00292526     History of Changes
Other Study ID Numbers: IEO S67/500
Study First Received: February 15, 2006
Last Updated: February 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on July 24, 2017