Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

University of Sao Paulo200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Breast Cancer Heart Failure Cardiotoxicity

Interventions

CarvedilolDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart Institute University of Sao Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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