Breast Cancer, Cardiotoxicity, Heart Failure
Conditions
Keywords
Breast Cancer, Heart Failure, Cardiotoxicity, Biomarkers
Brief 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.
Interventions
DRUGCarvedilol
50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
DRUGPlacebo
Placebo similar to the carvedilol up titration but wit no active drug.
Sponsors
Hospital A.C. Camargo
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.
Exclusion criteria
Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers. Patients with HER 2 expression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle. | 96 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 96 weeks |
Countries
Brazil
Outcome results
None listed