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Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Primary Purpose

Cardiotoxicity, Chemotherapeutic Toxicity

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Enalapril

About this trial

This is an interventional prevention trial for Cardiotoxicity focused on measuring Chemotherapy induced cardiotoxicity, Troponin, Heart failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

European Institute of Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

enalapril arm

Arm Description

treatment with enalapril

Outcomes

Primary Outcome Measures

Incidence of chemotherapy-induced cardiotoxicity

Secondary Outcome Measures

Major adverse cardiac events, including death.

Full Information

NCT ID

NCT00292526

First Posted

February 15, 2006

Last Updated

February 7, 2017

Sponsor

European Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00292526

Brief Title

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Official Title

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 2000 (Actual)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Institute of Oncology

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiotoxicity, Chemotherapeutic Toxicity

Keywords

Chemotherapy induced cardiotoxicity, Troponin, Heart failure

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enalapril arm

Arm Type

Experimental

Arm Description

treatment with enalapril

Intervention Type

Drug

Intervention Name(s)

Enalapril

Intervention Description

enalapril orally administered

Primary Outcome Measure Information:

Title

Incidence of chemotherapy-induced cardiotoxicity

Time Frame

12 month period

Secondary Outcome Measure Information:

Title

Major adverse cardiac events, including death.

Time Frame

12 month period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlo M Cipolla, MD

Organizational Affiliation

European Institute of Oncology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Daniela Cardinale, MD

Organizational Affiliation

European Institute of Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

European Institute of Oncology

City

Milan

ZIP/Postal Code

20141

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15148277

Citation

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. doi: 10.1161/01.CIR.0000130926.51766.CC. Epub 2004 May 17.

Results Reference

background

PubMed Identifier

10933366

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. doi: 10.1016/s0735-1097(00)00748-8.

Results Reference

background

Learn more about this trial

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

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