Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity
The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Carvedilol||
50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
|Placebo Comparator: Control||
Placebo similar to the carvedilol up titration but wit no active drug.
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.
|Contact: Edimar Alcides Bocchi, PHDfirstname.lastname@example.org|
|Contact: Silvia Moreira Ayub-Ferreira, PHDemail@example.com|
|Heart Institute University of Sao Paulo||Recruiting|
|Sao Paulo, Brazil, 05403-000|
|Contact: Edimar Alcides Bocchi, PHD +551126615419 firstname.lastname@example.org|
|Contact: Silvia Moreira Ayub-Ferreira, PHD +551126615419 email@example.com|
|Sub-Investigator: Monica Samuel Avila, MD|
|Sub-Investigator: Solange Moraes Sanches, MD|
|Principal Investigator:||Edimar Alcides Bocchi, PHD||Heart Institute of University of Sao Paulo|