Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Cardiotoxicity Clinical Trial

Official title:

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292526
• Other study ID #: IEO S67/500
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2006
• Last updated: February 7, 2017
• Start date: November 2000
• Est. completion date: November 2011

Study information

• Verified date: February 2017
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Chemotherapeutic Toxicity

Intervention

Drug:
• Enalapril
enalapril orally administered

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chemotherapy-induced cardiotoxicity		12 month period
Secondary	Major adverse cardiac events, including death.		12 month period