Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

Phase 3

Completed

• Conditions: Breast Cancer; Heart Failure; Cardiotoxicity
• Interventions: Drug: Placebo; Drug: Carvedilol

• Registration Number: NCT01724450
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Study Start: 2013-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Carvedilol	Carvedilol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Heart Institute University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil