Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.
Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.
Edimar Alcides Bocchi, PHD
Heart Institute of University of Sao Paulo
Brazil: Ethics Committee