Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity (Ceccy)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01724450|
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Heart Failure Cardiotoxicity||Drug: Carvedilol Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
|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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724450
|Heart Institute University of Sao Paulo|
|Sao Paulo, Brazil, 05403-000|
|Principal Investigator:||Edimar Alcides Bocchi, PHD||Heart Institute of University of Sao Paulo|