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Completed

NCT Number: NCT01724450

Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Heart Institute University of Sao Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Hospital A.C. Camargo
  • Instituto do Cancer do Estado de São Paulo

Registry information

Official study title

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

Acronym: Ceccy

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2012
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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