Clinical Trial: Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.

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

Detailed Summary:

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.

Sponsor: University of Sao Paulo

Current Primary Outcome: Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle. [ Time Frame: 96 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction. [ Time Frame: 96 weeks ]

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: June 11, 2012
Date Started: June 2012
Date Completion: October 2017
Last Updated: March 4, 2016
Last Verified: March 2016