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Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Phase 4
Completed
Conditions
Cardiotoxicity
Chemotherapeutic Toxicity
Interventions
Registration Number
NCT00292526
Lead Sponsor
European Institute of Oncology
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
114
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
enalapril armEnalapriltreatment with enalapril
Primary Outcome Measures
NameTimeMethod
Incidence of chemotherapy-induced cardiotoxicity12 month period
Secondary Outcome Measures
NameTimeMethod
Major adverse cardiac events, including death.12 month period

Trial Locations

Locations (1)

European Institute of Oncology

🇮🇹

Milan, Italy

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