Ceccy: Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01724450

Collaborator

Hospital A.C. Camargo (Other), Instituto do Cancer do Estado de São Paulo (Other)

200

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Heart Failure Cardiotoxicity	Drug: Carvedilol Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carvedilol	Drug: Carvedilol 50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
Placebo Comparator: Control	Drug: Placebo Placebo similar to the carvedilol up titration but wit no active drug.

Arm

Intervention/Treatment

Active Comparator: Carvedilol

Drug: Carvedilol

50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day

Placebo Comparator: Control

Drug: Placebo

Placebo similar to the carvedilol up titration but wit no active drug.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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