NCT01724450

Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Breast Cancer
• Heart Failure
• Cardiotoxicity

Interventions

Type	Name	Description
DRUG	Carvedilol	50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
DRUG	Placebo	Placebo similar to the carvedilol up titration but wit no active drug.

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2012-11-09
• Last updated: 2018-02-05

Locations

1 site across 1 country: Brazil