Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

• Sponsor: European Institute of Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00292526
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arm: 1
• Actual Duration (Months): 132
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiotoxicity; Chemotherapeutic Toxicity	Drug: Enalapril	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
• Actual Study Start Date: Nov 1, 2000
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: enalapril arm treatment with enalapril	Drug: Enalapril; enalapril orally administered

Outcome Measures

Primary Outcome Measures

1. Incidence of chemotherapy-induced cardiotoxicity [12 month period]

Secondary Outcome Measures

1. Major adverse cardiac events, including death. [12 month period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

• Responsible Party: European Institute of Oncology
• ClinicalTrials.gov Identifier: NCT00292526
• Other Study ID Numbers: IEO S67/500
• First Posted: Feb 16, 2006
• Last Update Posted: Feb 9, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by European Institute of Oncology: Chemotherapy induced cardiotoxicity; Troponin; Heart failure
• Additional relevant MeSH terms: Cardiotoxicity; Enalapril

Study Results

No Results Posted as of Feb 9, 2017