Prevention of Chemotherapy-Induced Cardiotoxicity in High-Risk Patients

This study has been completed.

First Received on February 15, 2006. No Changes Posted

Sponsor:	European Institute of Oncology
Information provided by:	European Institute of Oncology
ClinicalTrials.gov Identifier:	NCT00292526

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 IV

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:

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

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:

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.

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 February 09, 2012