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Prevention of Chemotherapy-Induced Cardiotoxicity in High-Risk Patients

Information source: European Institute of Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-Induced Cardiotoxicity Revealed by TnI Increase.

Intervention: oral enalapril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: European Institute of Oncology

Official(s) and/or principal investigator(s):
Carlo M Cipolla, MD, Study Director, Affiliation: European Institute of Oncology
Daniela Cardinale, MD, Principal Investigator, Affiliation: European Institute of Oncology

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Primary outcome: Incidence of chemotherapy-induced cardiotoxicity

Secondary outcome: Major adverse cardiac events, including death.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): 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

Locations and Contacts

European Institute of Oncology, Milan 20141, Italy
Additional Information

Related publications:

Cardinale D, Sandri MT, Colombo A, Colombo N, Boeri M, Lamantia G, Civelli M, Peccatori F, Martinelli G, Fiorentini C, Cipolla CM. Prognostic value of troponin I in cardiac risk stratification of cancer patients undergoing high-dose chemotherapy. Circulation. 2004 Jun 8;109(22):2749-54. Epub 2004 May 17.

Cardinale D, Sandri MT, Martinoni A, Tricca A, Civelli M, Lamantia G, Cinieri S, Martinelli G, Cipolla CM, Fiorentini C. Left ventricular dysfunction predicted by early troponin I release after high-dose chemotherapy. J Am Coll Cardiol. 2000 Aug;36(2):517-22.


Last updated: February 15, 2006

Page last updated: August 23, 2015

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