ClinicalTrials.Veeva

Menu

Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity (Ceccy)

U

University of Sao Paulo

Status and phase

Completed
Phase 3

Conditions

Cardiotoxicity
Breast Cancer
Heart Failure

Treatments

Drug: Placebo
Drug: Carvedilol

Study type

Interventional

Funder types

Other

Identifiers

NCT01724450
Ceccy Trial

Details and patient eligibility

About

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

Full 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.

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

Carvedilol
Active Comparator group
Treatment:
Drug: Carvedilol
Control
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems