Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

Last updated: January 31, 2018
Sponsor: University of Sao Paulo
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Chest Pain

Cancer

Treatment

N/A

Clinical Study ID

NCT01724450
Ceccy Trial
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients diagnosed with breast cancer, with an indication of chemotherapy that includesanthracycline.

Exclusion

Exclusion Criteria: Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previoussymptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease;Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to theuse of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptorblockers or β-blockers. Patients with HER 2 expression

Study Design

Total Participants: 200
Study Start date:
April 01, 2013
Estimated Completion Date:
June 30, 2017

Study Description

Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies.

Initial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.These patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.

Connect with a study center

  • Heart Institute University of Sao Paulo

    Sao Paulo, 05403-000
    Brazil

    Site Not Available

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